Volumetric Changes and Graft S

THE UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER
GRADUATE COLLEGE
VOLUMETRIC CHANGES AND GRAFT STABILITY IN LATERAL WINDOW SINUS
AUGMENTATION: A PROSPECTIVE CLINICAL TRIAL
A THESIS
SUBMITTED TO THE GRADUATE FACULTY
in partial fulfillment of the requirements for the
Degree of
Master of Science
By
AHMAD SEDEQI
Oklahoma City, Oklahoma
2020
0
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ãCOPYRIGHT
by
Ahmad Sedeqi
May 8, 2020.
2
ACKNOWLEDGMENTS
It is with deep gratitude and appreciation that I acknowledge the professional guidance of Dr.
Tapan Koticha, Dr. Fernando Suarez for their constant encouragement and support throughout
the course of the research study. My gratitude goes to the other members of the committee, Dr.
Yacoub Al Sakka, Dr. Mohammed Felemban, and Dr. Farah Masood. Their academic help and
recommendations helped me in proceeding with this project. I am grateful to the faculty of the
Department of Oral Pathology of the University of Oklahoma Health Sciences Center, especially
Dr. David Lewis for his valuable contribution. I would also like to thank the staff of the Graduate
Periodontics department of the University of Oklahoma for their constant help.
3
TABLE OF CONTENTS
LIST OF TABLES .......................................................................................................5
LIST OF FIGURES .....................................................................................................6
ABSTRACT ………………………………………………………………………….8
Chapter
I. INTRODUCTION AND LITERATURE REVIEW ...................................... 10
II. MATERIALS AND METHODS ................................................................... 13
III. RESULTS ....................................................................................................... 21
IV. DISCUSSION ................................................................................................. 26
V. SUMMARY .................................................................................................... 34
BIBLIOGRAPHY ....................................................................................................... 72
4
LIST OF TABLES
Table Page
1. Schedule of events………………………………………………………....... 36
2. Patients characteristics and implant size......................................................... 37
3. Demographic and pre-surgical variables per sinus stratified by
randomization group…………........................................................................ 38
4. CBCT pre-surgery measurements per implant …………………………...…. 39
5. Clinical sinus augmentation surgery measurement …………………………. 40
6. Maximum bone graft height per implant…………………............................. 41
7. Bone graft height between-group and within group comparisons ………....... 42
8. Maximum bone graft width at implant site (M-D) ………………………….. 43
9. Maximum bone graft width at sinus site (A-P) ……………………………… 44
10. Membrane thickness …………………………………………………………. 45
11. Membrane thickness between-group and within group comparisons ……. ….46
12. Graft volume …………………………………………………………………. 47
13. Graft volume between-group and within group comparisons ………………. 48
14. Void volume …………………………………………………………………. 49
15. Graft volume outside sinus ………………………………………………….. 50
16. Comparison of membrane thickness at 2 weeks between those who did and
did not have bone graft outside sinus in group 1 ..…………………………… 51
17. Pearson correlation between pre-surgical sinus area and % shrinkage
in post-surgical bone height….…………………………………………………… 51
5
LIST OF FIGURES
Figure Page
1. Study outline and sequence of events ……………………………………..... 53
2. Study outline and sequence of events ………………………………………. 54
3. Intraoperative lateral view of bone graft inside lifted maxillary sinus cavity. 55
4. lateral window sites were covered by a resorbable collagen membrane ……. 56
5. Primary closure after sinus augmentation surgery …………………………... 56
6. Lateral Window Dimensions ………………………………………………... 57
7. STL file image of pre-operative planning for implant positions ……………. 58
8. Pre-operative CBCT linear measurements ………………………………….. 59
9. 2 weeks and 6 months CBCT linear measurements ………………………… 60
10. (GAP1) Maximum bone graft width (Anterior-Posterior) (mm) at
2 weeks CBCT and (GAP2) at 6 months CBCT..………………….……………. 61
11. Maxillary sinus bone graft 3D volumetric analysis using ITK-SNAP
with different cross sectional presentation……………….……………….….. 62
12. Maximum bone graft height group 1 per implant …………………………… 63
13. Maximum bone graft height group 2 per implant …………………………… 63
14. Maximum bone graft shrinkage between groups ……………………………. 63
15. Maximum bone graft width (M-D) group 1 per implant …………………….. 64
16. Maximum bone graft width (M-D) group 2 per implant ……………………. 64
17. Maximum bone graft width (M-D) shrinkage between groups …………...… 64
18. Maximum bone graft width (A-P) shrinkage between groups …………….... 65
19. Graft volume at 2 weeks and 6 months in group 1 ………………….……..… 66
6
LIST OF FIGURES CONTENUED
20. Graft volume at 2 weeks and 6 months in group 2 ………………………… 66
21. Graft volume shrinkage between groups ………………………………..…. 66
22. Void volume at 2 weeks and 6 months in group 1 …………………………. 67
23. Void volume at 2 weeks and 6 months in group 2 …………………………. 67
24. Void volume shrinkage between groups ………………………………...…. 67
25. Bone graft outside sinus cavity at (C) coronal cross section with
and without color mapping (S) sagittal cross section………………………. 68
26. Graft volume outside sinus at weeks and 6 months in group 1 ………….… 69
27. Graft volume outside sinus at weeks and 6 months in group 2 …………..... 69
28. Graft volume outside sinus shrinkage in two groups ………………………. 69
29. Histologic section of one of the samples of group 1 ……………………….. 70
30. Histologic section of one of the samples of group 2 ……………………….. 71
7
ABSTRACT
Objective: The aim of this prospective randomized clinical study was to compare the stability and
volumetric changes of two different graft material used for lateral window sinus augmentation
procedure (LWSA). In addition, different variables known to affect bone stability and remodeling
with regard to the augmentation procedure were evaluated. Also, histological analysis was
performed of the augmented site.
Materials and methods: In this randomized clinical prospective study, sixteen patients with total
twenty sinuses indicated for LWSA were included. In Group 1, the sinus was grafted with 100%
anorganic bovine bone mineral xenograf (MinerOss X). In group 2, the sinus was grafted with a
mixture of anorganic bovine bone mineral xenograft (MinerOss X) and mineralized cortical
allograft (MinerOss). Cone beam computed tomography (CBCT) was taken before, 2 weeks and
6 months after sinus surgery. CBCT volumetric analysis was performed to evaluate graft
volumetric changes in addition to linear measurements related to graft dimensions. Biopsies were
obtained after 6 months at time of implant placement for histological analysis.
Results: Total of 20 sinuses (10 per group) received LWSA which later received total of 26
implants that were included in the analysis. No statistical significant difference was found between
group 1 and group 2 in regard of mean graft volume reduction percentage 14.87 ± 16.60 , 18.06 ±
9.81 % respectively P= 0.3258, nor for any linear measurements mean reductions (GH, GMD,
GAP) between the two groups. Sinus width at implant site for group 1 showed weak positive (+ve)
correlation with maximum bone height shrinkage and sinus membrane thickness at 2 weeks might
have an effect on sinus augmentation outcomes.
Conclusion: Within the limitations of this study, results show that both anorganic bovine bone
mineral (ABBM) alone or in combination with mineralized cortical allograft (ABBM + MA) graft
8
material utilized in LWSA showed good stability and were comparable in regard to volumetric
and linear dimensions stability after 6 months. Further studies are needed to confirm findings in
regard of sinus membrane thickness and sinus width effects on LWSA outcomes.
Keywords: bone replacement graft, cone-beam computed tomography, lateral window approach,
sinus augmentation
9
CHAPTER I
INTRODUCTION
The loss of maxillary posterior teeth will result in bone loss and maxillary sinus pneumatization
which will limit the amount of bone available for future implant placement (Hatano et al. 2004).
To overcome this vertical ridge deficiency sinus augmentation is crucial to provide the adequate
bony housing for any implant procedure. Maxillary sinus augmentation procedure was first
introduced by Boyne and James in 1980 (Boyne et al. 1980). Later in 1994, Summers introduced
osteotome technique. One major drawback for osteotome is inability to visualize what is happing
in the sinus and limited elevation gain (Pjetursson et al. 2000). Important factor in sinus lift, is to
know the required amount of bone graft material associated with the extent of vertical bone height
elevation. In order to accurately study the sinus anatomy and related anatomical variations that can
play a role in sinus lift procedure, a detailed view of sinus area should be achieved. Also, to
evaluate the stability of the graft material that was used in the sinus augmentation procedure over
time is very important. Since it will have a huge impact for future implant placement. Cone beam
computed tomography (CBCT) can help clinicians greatly to plan for sinus lift procedures prior to
the surgery. Which will minimize procedure complications (Benvidas et al. 2012). Also, it will
help evaluating volumetric changes of bone graft used, which is the main concern regarding
implant placement.
In the studies looking into volumetric changes in sinus augmentations, it was shown
that graft volume shrinkage can vary according to graft material, with xenograft showing less
shrinkage percentage compared to an allograft. In which DBB group showed the least reduction
10
percentage 8.14±3.7%. And mineralized allograft (MA) and composite group of mixture of MA
and demineralized allograft showed 19.38±9.2 %, 24.66±4.68 shrinkage at 6 months respectively
(Gultekin et al 2016). And when comparing a xenograft with a mixture of xenograft with allograft
aimed at evaluating percentage of graft volume reduction, no statistically significant difference
was found between the two groups. (Kim et al 2013). Another study comparing histologic
presentation of xenograft alone to a combination of xenograft and allograft showed high
percentage of new bone formation in both groups with no significant differences (Xavier et al
2016)
Hence, the purpose of this research was to compare the stability and volumetric changes of
xenograft graft compared to a mixture of xenograft and allograft in lateral window sinus
augmentation. An additional aim was to relate the volumetric differences to linear measurements
to represent an actual situation of implant planning. The Null Hypothesis tested was that there is
no significant difference in volumetric changes of graft material in sinus augmentation procedure
between two groups of graft material in sinus augmentation procedure.
Specific Aims/Hypothesis:
Specific aim 1: Compare the volumetric and linear changes between two groups of graft
material in sinus augmentation procedure (anorganic bovine bone mineral xenograft
alone compared to a mixture of allograft and anorganic bovine bone mineral xenograft).
Null Hypothesis (H0): There is no significant difference in volumetric and linear changes of graft
material in sinus augmentation procedure between two groups of graft material in sinus
11
augmentation procedure (anorganic bovine bone mineral xenograft alone compared to a mixture
of allograft and anorganic bovine bone mineral xenograft).
Alternative Hypothesis (H1): There is significant difference in volumetric and linear changes of
graft material in sinus augmentation procedure between two groups of graft material in sinus
augmentation procedure (anorganic bovine bone mineral xenograft alone compared to a mixture
of allograft and anorganic bovine bone mineral xenograft).
Specific aim 2: Evaluate and identify potential variables that may affect the stability of the
graft in sinus augmentation in relation to graft volume and linear changes.
Null Hypothesis (H0): It is not possible to identify potential variables that may affect the stability
of the graft in sinus augmentation in relation to graft volume and linear changes.
Alternative Hypothesis (H1): It is possible to identify potential variables that may affect the
stability of the graft in sinus augmentation in relation to graft volume and linear changes.
Significance
Graft material stability over time is crucial in implant placement and implant planning in
maxillary sinus augmentation. Therefore, an accurate and better understanding of volumetric
changes that a graft material undergoes in maxillary sinus augmentation procedure will help to
provide a better implant placement planning that will in addition reflect on future prosthetic
rehabilitation. This prospective and randomized controlled clinical trial should allow clinicians to
reach to a better treatment planning in implant placement in patients who are in need of
maxillary sinus augmentation.
12
CHAPTER II
MATERIALS AND METHODS
This study was designed following the privacy regulations of the federal Health Insurance
Portability and Accountability Act of 1996 (HIPAA) and was conformed with the ethical
guidelines of the 1975 Declaration of Helsinki as reflected in obtainment of approval by the
University of Oklahoma’s institutional review board human research board of human protection .
This investigation was conducted in the Department of Graduate Periodontics and in the
department of Implantology at the School of Dentistry - University of Oklahoma, Oklahoma City,
Oklahoma, USA
II.1 Patients
All adult patients that were indicated for lateral window sinus augmentation at the Graduate
Periodontics Clinic were evaluated for inclusion in the study. The Inclusion criteria were: adult
patients ≥ 18 years old ; in need of sinus augmentation utilizing lateral window sinus technique;
presence of residual bone height of < 8 mm; good oral hygiene (<40% plaque score, O’Leary et
al. 1972); periodontally stable and willingness to fulfill all study requirements. The exclusion
criteria were: currently smoking > 10 cigarettes / day; pregnant, expecting to become pregnant or
lactating mothers; uncontrolled Diabetes Mellitus (HbA1c >7); medical condition that may
influence the outcome (neurologic or psychiatric disorders, systemic infections); history of oral
bisphosphonates or IV bisphosphonates use; poor oral hygiene (plaque score >40% based on
13
O’Leary et al. 1972) and significant pathology in the region of interest that may compromise the
procedure.
Before inclusion, a detailed explanation and written informed consent form were provided to all
subjects. Only those who agreed to undergo the protocol were included in the study. After
enrolment each subject was given an identification number. The assignment of graft material to
each identification number was randomized by drawing a paper from an envelope before the sinus
surgery. (Table. 1) (Fig. 1)(Fig. 2)
II.2 Surgical procedure and graft materials
All patients received a bolus antibiotic prophylaxis of 2g Amoxicillin or 600 mg clindamycin in
case of penicillin allergy 30-60 min before the surgical procedures according to Graduate
Periodontics pre-surgical anti-infective protocol. Also, a one-time mouth rinse of Chlorhexidine
0.12% immediately before starting the procedure was used. All surgeries were performed under
local anesthesia. In addition, some surgeries were performed under IV sedation. Midcrestal
incision was placed and joined by appropriate vertical releasing incision(s). After the reflection of
the full thickness mucoperiosteal flap, lateral window osteotomy was performed using both rotary
instrument and piezo under saline irrigation in both groups. Sinus membranes were elevated and
sinus augmentation sinus was performed using the graft material according to the group
randomization. Group 1 patients received 100% anorganic bovine bone mineral xenograft of 500–
1000 microns particle size (MinerOss XÒ, Biohorizons, USA). While group 2 patients received a
mixture of anorganic bovine bone mineral xenograft (MinerOss XÒ, Biohorizons, USA) and
mineralized cortical allograft of 300-1000 microns particle size (MinerOssÒ, Biohorizons, USA)
with a ratio of (0.8:1) respectively (Fig. 3). Bone graft amount used was reported. After the graft
14
material was properly placed in both groups all lateral window sites were covered by a resorbable
collagen membrane (Mem-lokÒ, Biohorizons, USA) to completely cover the window and extend
at least 2 mm from margins of the lateral window osteotomy (Fig. 4). In case of a manageable
sinus perforation, a resorbable collagen membrane was utilized for closure of the perforation
(Mem-lokÒ, Biohorizons, USA). Soft tissue was sutured with PTFE sutures (Cytoplast - PTFE
suture) and chromic gut using either a simple interrupted technique, a mattress technique or a
combination. Primary closure of the site was achieved (Fig. 5). Patients received antibiotic post-
operatively of Amoxicillin 500 mg 1x3 for 7 days. If patients were allergic to Amoxicillin, an
alternative was given. Also, patients were instructed to rinse twice daily with warm water and salt
1 minute, 2 times per day for the first week. Patients returned for a post-operative evaluation visit
at 2 and 4 weeks. Sutures were removed 10-14 days following the surgical appointment.
II.3 Implant placement, bone biopsy and restoration
All patients received a prosthetic consultation and implant positions were planned in order for the
implants to receive a screw retained restorations virtually before the sinus augmentation surgery.
All implants positions were confirmed and an STL scan files were exported. This STL file was
used as reference point (Fig. 7).
Simultaneous implant placement was done when applicable in both groups at the time of sinus
augmentation procedure. If not applicable, delayed implant placement was performed later in a
separate surgery for implant placement 6 months after sinus augmentation procedure. All patients
received (Tapered Internal implants Ò, Biohorizons, USA). During implant placement bone biopsy
cores were obtained from both groups using trephine bur (2.3 mm interior diameter and 2.8 mm
exterior diameter) (Brasseler USA®). Then they were fixed in 10% formalin (pH 7). During
implant placement, if bone graft was needed, bone graft type was reported. At time of implant
15
placement either healing abutments or cover screws were provided based on clinician decision at
time of implant placement. Implants uncovering procedure were performed at 3-4 months after the
implant placement. Patients proceeded with implant restoration according to restorative plan
within 3-4 months after implant placement.
II.4 Clinical measurements
Clinical measurements were measured intra-operatively using a periodontal probe. It included:
- Lateral window location: indicating the position (molar region, molar-premolar region or
premolar region)
- Lateral window length in (mm): the mesial-distal length in middle of the lateral window
osteotomy (Fig. 6)
- Lateral window height in (mm): the apical-coronal height in middle of the lateral window
osteotomy (Fig. 6)
- Approximate window dimensions (AWD) (mm2): lateral window length multiplied by the
height of the window
- Lateral window distance from alveolar ridge in (mm): the distance from base of the lateral
window osteotomy to the alveolar ridge from the middle of the osteotomy (Fig. 6)
- Bone graft type: according to the randomization
- Bone graft quantity in (mm3)
16
II.5 CBCT imaging, linear and 3D volumetric evaluation
CBCTs were obtained and evaluated at 3 time points. Pre-operatively, 2 weeks after sinus
augmentation procedure and 6 months after sinus augmentation procedure. CBCT images were
obtained using a Planmeca ProMax 3D Mid (Helsinki, Finland) CBCT scanner. Images were taken
at 90 kVp, 8-12.5 mA, 17 seconds and a 200 𝜇m voxel size. CBCT data was exported as DICOM
files.
All CBCT analysis were performed under standardized conditions at the same workplace (macOS
Catalina, USA) using 15.4-inch monitor (2880 x 1800) (Intel HD Graphics 630 1536 MB). For
linear measurements, the CBCT scans were analyzed using BlueSkyPlan 4 (Version 4.7.20) (Blue
Sky Bio, LLC, USA), an implant imaging software for pre, two weeks after sinus augmentation
procedure and 6 months after sinus augmentation procedure. The CBCT images were analyzed by
one examiner using axial, coronal, and sagittal views. For all linear measurements standardization
, an STL file for each patient with the fixed exact planned implant position(s) from the pre-
operative CBCT was exported, duplicated and superimposed over the two weeks and six months
CBCTs. Measurements were taken for each planned implant site.
Linear measurements on CBCT scans included:
Measurements at pre-operative CBCT at implant site (Fig. 8)
- Residual bone height (mm) (at middle of planned implant position) Ho at pre-operative
CBCT. This was taken at the coronal view bisecting the implant.
17
- Residual bone thickness (mm) (at implant position): This was taken at half level of the
residual bone height (Ho) at line dissecting the long axis of the planned implant at 90° at
the coronal view bisecting the implant.
- Sinus width pre-operatively only (mm) (at 3 points; at 3mm, 6mm, 9mm above sinus floor
of the middle of exact implant position): This was taken at the coronal view bisecting the
implant.
- Approximate relative sinus width area (ARSWA) (mm²): Since sinus cavity represents a
trapezoidal space, the approximate relative width area was measured by multiplying the
sum of the total base lengths (lower base length of sinus width at the 3mm point + base
length at 9mmm) X the fixed height of the trapezoidal shape of 6 mm divided by 2
- Sinus membrane thickness (mm): To at pre-operative CBCT
- Presence of sinus septa: yes or no
Measurements at 2 weeks and 6 months CBCT at implant site: (Fig. 9, Fig. 10)
- Maximum bone graft height excluding residual bone (mm) (GH1) at 2 weeks CBCT and
(GH2) at 6 months CBCT. This represents maximum bone graft height within the coronal
view of the implant. In case of obvious void in the coronal aspect, it was excluded from
the total height.
- Maximum bone graft width (Mesial-Distal) (mm) (GMD1) at 2 weeks CBCT and (GMD2)
at 6 months CBCT (mm): This represents maximum bone graft width mesio-distally at a
line of a 90 degrees of half distance of the (GH1) at the coronal view bisecting the implant.
- Maximum bone graft width (Anterior-Posterior) (mm) (GAP1) at 2 weeks CBCT and
(GAP2) at 6 months CBCT: This represents the anterior-posterior maximum spread of the
18
bone graft at a line that makes 90 degrees with long axis of the implant at best sagittal cross
section.
- Sinus membrane thickness: T1 at two weeks CBCT and T2 at 6 months CBCT
- All CBCT linear measurements was based on implant sites. Ex. If the same sinus site
received more than one implant all measurements were taken for each implant included in
the analysis. Except for maximum bone graft width (Anterior-Posterior), which was based
on sinus site even at multiple implants within the same sinus site.
3D volumetric comparisons at 2 weeks and 6 months CBCT at sinus site:
For 3D volumetric analysis, software ITK-SNAP (Version 3.8.0) (www.itksnap.org, Yushkevich
et al. 2006) was used to evaluate the different parts of the bone grafts at both 2 weeks and 6 months
CBCT. The files were imported as DICOM files. Dimensions were: (x:401, y: 401, z: 401) and
contrast intensity was kept with no change at a range of minimum of -1000 and maximum of 3095.
Voxel spacing was 0.2 and color map was kept at grayscale. The active contour semi-automatic
3D segmentation was utilized to perform the 3D volumetric analysis. The classification pre-
segmentation mode used was to create a speed image of different parts of the graft. The main part
of the graft was identified through sagittal, coronal and axial cross sections. Parts identified were
main graft inside the sinus, voids, graft material outside the sinus. After creating 3D representation
of the graft, volumes were calculated in mm³ for both 2 weeks and 6 months CBCT for each sinus
site. (Fig. 11)
19
II.6 Histology
Immediately after harvesting, all biopsy specimens were appropriately placed in labeled bottles
containing 10% neutral-buffered formalin solution. Following demineralization, cores were
dehydrated, and specimens were sectioned in the sagittal plane along the full length of the
specimen. Samples were stained with conventional hematoxylin-eosin (H&E) technique and cover
slipped for histologic analysis. Images were obtained using a bright field optical microscope with
a digital camera connected to a computer. Vital bone (VB), remaining bone graft particle (RBG),
and nonmineralized tissue (NMT) were identified.
II.7 Statistical analysis
Between group analysis was carried out with Wilcoxon rank sum test for pre-surgical
measurements, linear measurements at 2 weeks , 6 months and shrinkage percentage %, graft
volume at 2 weeks, 6 months and shrinkage percentage % in addition to Pearson correlation
between pre-surgical sinus area and % shrinkage in post-surgical bone graft height. Wilcoxon rank
sum test was applied for comparison of membrane thickness at 2 weeks between those who did
and did not have bone graft outside sinus at the 2 weeks post sinus surgery (It was possible to
apply only in group 1). Paired T-test was used to analyze the within group differences. For all
analyses, p-values of <0.05 are considered significant.
20
CHAPTER III
RESULTS
Study population
19 patients (with total 24 sinuses) agreed to participate, signed the consent form and were enrolled
in study. 4 sinus sites were excluded , one patient dropped out before the 6 months CBCT, two
patients were excluded from the analysis because of unmanageable sinus perforation during sinus
augmentation surgery and one site was excluded due to sinus infection after sinus augmentation
and the graft material was removed surgically. At the end, total of 16 patients with 20 sinuses (9
males and 7 females) were included in the study. Four of these patients with bilateral sinus sites.
The mean age of patients was 57 years (range, 21 to 69). None of the individuals were smokers.
(Table. 2-1)
Clinical findings
Sinus membrane perforation in total sites including the excluded sites was 20.83% (5 of 24
sinuses). Soft tissue invasion into lateral window sites was noticed in 3 sinuses. But implant
placements were performed uneventfully for these sites. Implant placement was performed in all
the 20 sinuses included. A Total of 32 implants were placed. 26 of these implants met the inclusion
criteria and were included in the linear implant sites measurements. All implants placed were bone
level implants. (Tapered Internal implants Ò, Biohorizons, USA). The majority sizes of the 26
implants placed were of 4.6x12 mm (16 of 26 implants) followed by 4.6x10.5 mm (6 of 26
implants) , 4.2x12 mm (1 of 26 implants), 3.8x12 mm (2 of 26) and 4.6x9 mm (1 of 26 implants).
Primary stability was achieved in all implants (determined by insertion torque >35N/cm2). Only
21
one implant in patient (817 URS) was placed as 1 stage simultaneous with sinus augmentation
surgery and all remaining implants were placed at a 2nd stage 6 months after sinus augmentation.
CBCT pre-surgery linear measurements at implant and sinus site findings (Table. 3, 2-2)
For the pre surgery measurements, no statistical difference was found between the two groups.
The residual bone height (Ho) mean for group 1 and group 2 at implant site were (4.634 ± 2.218
mm) and (5.481 ± 2.963) respectively and per sinus it was (4.62 ± 1.70), (5.04 ± 2.48) respectively.
Approximate relative sinus area (mm²) mean for both groups were (70.412 ± 18.303) and (81.842
± 19.523) respectively. And sinus membrane thickness per sinus was (2.90 ± 4.15) for group 1 and
(1.43 ± 1.52) for group 2. For the 20 sinuses, sinus septa presence percentage was 70 % (14 of 20
sinuses ). The sinus widths at 3mm, 6mm, 9mm for both groups are reported in (Table. 3).
Clinical sinus augmentation surgery measurements (Table. 4)
The total mean of approximated graft material used for group 1 and group 2 were (3323.07 ±
1215.28 mm³) and (2907.69 ± 911.46 mm³) respectively. The means for Lateral window length
(mm), Lateral window height (mm) and Approximate window dimensions (AWD) (mm²) for
group 1 were (12.92 ± 4.78), ( 8.38 ± 1.80) and (104.07 ± 28.77) respectively. And for group 2 the
means were (12.84 ± 3.93), (7.92 ± 1.18) and (100.23 ± 28.31) respectively.
CBCT linear measurements at 2 weeks and 6 months findings
At implant site, maximum bone graft height mean values excluding residual bone (mm) (GH1) at
2 weeks CBCT and (GH2) at 6 months CBCT for group 1 were (11.74 ± 4.54), (9.33 ± 2.67)
respectively. That accounted for shrinkage percentage mean % for group 1 of (15.823 ± 19.521).
The maximum bone graft height mean values excluding residual bone (mm) (GH1) at 2 weeks
CBCT and (GH2) at 6 months CBCT for group 2 were (11.56 ± 3.83), ( 9.67 ± 3.53) respectively.
That made the shrinkage percentage mean % to be at (15.511 ± 19.835). The shrinkage percentage
22
of (GH) was the highest compared to M-D and A-P width for both groups. Interestingly, there was
no statistical difference between both groups in the shrinkage percentage p=0.6261. (Table. 5,6)
( Fig. 12, 13, 14)
For the Maximum bone graft width (Mesial-Distal) (mm) mean values at implant site (GMD1) at
2 weeks CBCT and (GMD2) at 6 months CBCT (mm) for group 1, they were (11.44 ± 2.77),
(10.41 ± 3.27) respectively. With a mean shrinkage percentage % of (5.44 ± 31.00). The values
for group 2 were (12.36 ± 4.14) (11.67 ± 4.59) respectively and a shrinkage percentage % mean
of (5.44 ± 20.73). Also for the GMD width shrinkage there was no statistical difference between
group 1 and group 2. (Table. 7) ( Fig. 15, 16, 17)
The Maximum bone graft width (Anterior-Posterior) (mm) showed the least shrinkage in both
groups compared to the other bone graft linear measurements. The mean values (GAP1) at 2 weeks
CBCT and (GAP2) at 6 months CBCT for group 1 and group 2 were (21.24 ± 7.67) (19.68 ± 4.75),
(19.41 ± 4.54) (18.33 ± 4.2471704) respectively. And it is worth to notice that group 1 had less
shrinkage compared to group 2. The mean shrinkage % for both groups were (1.69 ± 23.45) ( 4.57
± 17.24) respectively. (Table. 8) ( Fig. 18)
For sinus membrane thickness, there is almost a general trend of an increase in membrane thickness
at the two weeks CBCT followed by a decrease in the six months CBCT. That it is obvious in the
sinus membrane thickness means for both group 1 at pre, 2 weeks and 6 months CBCTs with the
means of (4.01 ± 5.61) (11.71 ± 6.54) (1.79 ± 1.76) respectively, and for group 2 (1.46 ± 1.47)
(6.29 ± 6.61) (3.30 ± 4.93) respectively. There was a small but significant between group
difference in the 2 week measurement for membrane thickness per sinus (P-value = 0.0378)
(Table. 9,10)
CBCT volumetric analysis at 2 weeks and 6 months findings
23
In regard of bone graft volume stability after 6 months of sinus augmentation surgery, group 1
showed less shrinkage percentage % compared to group 2. But this difference was not statistically
significant (P = 0.3258). The mean bone graft volume at 2w and 6 months for group 1 were
(1950.55 ± 1108.90) (1586.08 ± 940.95) with mean shrinkage % of (14.87 ± 16.60). In the other
hand the values for group 2 were (2363.1 ± 1238.04) (1975.75 ± 1161.68) and a shrinkage % of
(18.06 ± 9.81). (Table. 11,12) (Fig. 19, 20, 21)
Voids have been identified in 60 % of group1 and 80% of group 2 (6 of 10 sinuses group 1, 8 of
10 sinuses group 2). Shrinkage percentage % was significantly lower in group 1 compared to group
2 (49.31 ± 81.81) (86.84 ± 15.21) respectively. All voids showed at least a minimum of ~ 50 %
volume shrinkage in both groups (except patient 803 ULS in group 1 , where soft tissue invasion
at lateral window osteotomy site was noticed at the 6 months CBCT and void has almost doubled).
(Table. 13) (Fig. 22, 23, 24)
Another finding was bone graft material outside the maxillary sinus and it was detected in 50 %
of group 1 (5 of 10 sinuses) and 60 % of group 2 ( 6 of 10 sinuses) (Fig. 25). In all cases bone graft
was outside the maxillary bony housing bulging through the lateral window site, except one case
17 ULS in group 2 where the bone graft material has leaked into maxillary sinus space through
undetected sinus membrane perforation. And this patient was controlled with local antibiotic and
nasal maxillary rinses. And the 6 months CBCT showed uneventful healing and implants were
placed. The mean shrinkage percentage % for group 1 and group 2 were (44.63 ± 35.51), (90.98 ±
12.36) respectively. (Table. 14) (Fig. 26, 27, 28)
24
Histology findings
Total of 4 core samples were obtained and prepared in group 1 and 7 in group 2. Histologic analysis
revealed the presence of three different tissue compartments: VB (characterized by the presence
of osteocytes in the lacunae) and evident in the polarized representation of the sample, randomly
distributed RBG particles, and NMT. (Fig. 29) Organized lamellar bone was observed throughout
most samples (Fig 30). New vital bone apposition over remaining bone graft particles in both
groups demonstrated the osteoconductivity of such biomaterials (Fig. 29,30). In most samples,
NMT was compatible with fibrous connective tissue containing randomly distributed blood
vessels. No significant inflammatory infiltrate was observed in the samples.
25
CHAPTER III
DISCUSSION
The success of sinus augmentation surgery from the perspective of achieving its purpose will be
dependent on the ability of placing of dental implants of intended size and length after the sinus
augmentation. Graft materials used in sinus augmentations undergo shrinkage during healing.
(Hatano et al 2004, Gultekin et al 2016, Kim et al 2013, Xavier et al 2016, Sbordone et al 2013,
Mazzocco et al 2014, Zhang et al 2019) Various anatomical and surgical considerations have been
attributed to have an effect on sinus augmentation outcomes. (Zhang et al 2019, Avila et al 2010,
Avila et al 2012, Kawakami et al 2019). The aim of this study was to compare two bone graft
materials in regard of volumetric differences and relate that to linear measurements and identify
possible relative factors.
In regard of graft volumetric stability in this study, both groups showed significant volume
reduction between 2 weeks and 6 months CBCT, with group 1 receiving 100 % bovine bone graft
showing slightly better volumetric stability with mean shrinkage percentage of (14.87 ± 16.60)
after 6 months compared to a mixture of bovine bone and allograft in group 2 with a shrinkage
percentage of (18.06 ± 9.81). In comparison, a retrospective study showed that anorganic bovine
bone (ABBM) had the least shrinkage of 8.14±3.7% and mineralized allograft (MA) and a mixture
of MA and demineralized allograft groups showed 19.38 ± 9.2 %, 24.66 ± 4.68 respectively
(Gultkin et al 2016). Another prospective study found a median graft shrinkage at 6 months CBCT
of 31% and 12% in the fresh frozen bone (FFB) group and anorganic bovine bone (ABBM)group
respectively (Xavier et al 2016). In a CBCT study, shrinkage of allogenic bone and a 1:1 mixture
26
of allograft bone + xenogeneic graft material at 6 months was 20 % and 16 % respectively. They
concluded that no statistical significant difference was observed between the two materials. (Kim
et al 2013). Mazzocco et al reported an average volume contraction of 10% at 8 to 9 months after
maxillary sinus augmentation using ABBM and Zhang et al reported 22.7 % after 6 months using
ABBM. (Mazzocco et al 2014) (Zhang et al 2019).
These results are generally in accordance with the current study, with both group 1 (100 % of
anorganic bovine bone mineral) and group 2 (mixture of ABBM + MA) showing statistically
significant difference volume reduction between 2 weeks and 6 months. No statistically significant
difference was found between the two groups in regard of volume reduction percentage. The mean
graft volume reduction percentage of 14.87 ± 16.60 for group 1 is within the reported percentage
in the literature for similar bone graft material of 8.14 – 22.7 %. (Gultkin et al. 2016, Xavier et al.
2016, Mazzocco et al. 2014, Zhan et al. 2019) And the mean graft volume reduction for group 2
of 18.06 ± 9.81 is in accordance with percentage reported of 16 % (Kim et al 2013). It seems
adding the advantage of a slower remolding bone graft material (Schlegel et al 2003, Nishimoto et
al 2019) to mineralized allograft could help in increasing the volumetric stability even slightly in
sinus augmentation compared to an allograft alone. (Gultkin et al. 2016, Kim et al. 2013) In the
current study the ABBM + MA mixture in group 2 showed mean graft volume reduction of 18.06
± 9.81 compared to 20 - 24.66 % volume reduction for allograft alone (Gultkin et al 2016, Kim et
al 2013).
In the current study, void volume analysis within the bone graft showed that group 1 has less void
collapse than group 2. One possible reason could be attributed to slower remodelling ( Schlegel et
al. 2003, Nishimoto et al. 2019) in group 1 which can lead into void spaces being filled or
remodeled completely at a slower rate beyond the 6 months CBCT that was obtained in this study.
27
This is in accordance to a recent result for ABBM graft used in maxillary sinus augmentation of
29.44 % void volume shrinkage between 3 months and 2 years of after sinus augmentation . (Yang
et al 2019) Maybe a longer follow-up CBCT more than 6 months would indicate the time needed
for voids to remodel completely. In addition, the void spaces has not been proven to be replaced
by bone graft at the 6 months healing. In the current study, from volumetric results, voids
encountered in this study didn’t add to bone volume. But interestingly, subjects 4 ULS, 14 URS
where GH showed no reductions but slight increase, had voids in the most coronal area of the bone
graft at the 2 weeks. The maximum bone height was taken just short of the void. At least, in those
patients voids could have remodeled to add to linear graft height at 6 months. In the other hand, in
two in vivo studies, void initially occupied by the coagulum after sinus membrane elevation shrank
substantially during the observation period. (Scala et al. 2010,2012)
Bone graft material outside sinus is one finding that was encountered and analyzed in the study.
With relatively high percentage of such finding prevalence at 2 weeks in this study 50 % in both
groups and a mean volume of 365 mm3 that accounts for 19% of total graft volume in group 1,
such finding must be taken into consideration. It might not have an effect on the graft volume
stability inside the sinus but it would relate into how much graft material have been used pre
surgically and how much graft volume would be useful to place the implant after healing. In regard
to the factors that could have an influence of such finding, it was related to the 2 weeks post-
surgery sinus membrane thickening. in a CBCT study by Nosaka et al, 100 % of total 132 sinuses
included for LWSA showed postoperative swelling of the maxillary sinus membrane 1 week after
sinus floor augmentation and disappeared spontaneously in 96.2% three months after surgery.
Their results suggested that the extent of the postoperative swelling did not depend on the area of
the detachment. And a complication of this postoperative swelling of the sinus membrane was
28
migration of the β-TCP granules. They concluded that when the postoperative swelling was more
than one third of the sinus space, the pressure of the swelling was sufficiently strong to push the
resorbable membranes out of the lateral window. (Nosaka et al. 2015) In the current study, 80 %
(18 of 20 total sinuses ) showed sinus membrane thickness increase at 2 weeks post operatively
and 80 % resolution at 6 months post LWSA. There was a small but significant difference between
groups in the 2 week measurement with group 1 being thicker. In a histological study in monkey
model, this membrane thickening was related to a temporary inflammatory cell infiltration due to
mechanical stimulation from elevation of the sinus membrane during sinus floor augmentation .
And at 20 days after surgery, the sinus mucosa presented a normal aspect with inflammatory
infiltration of limited size. (Scala et al. 2010,2012) In the current study specifically, when
analyzing the comparison of membrane thickness at 2 weeks between those who did and did not
have bone graft outside sinus, the presence of graft material outside maxillary sinus at 2 weeks
post-surgery was associated with thicker membrane at 2 weeks (P= 0.0283). In group 1 (4 of 5
total sinuses with graft outside maxillary sinuses) are the same 4 sinuses with thickest membrane
thicknesses within the group with sinus membrane thickness mean for those patients of 17.727 mm
which is significantly higher than the average for group 1. (Table. 15) The same finding can’t be
applied in group 2. Since only 3 sites would be analyzed. Further studies will be needed to confirm
the relation between sinus membrane thickness post operatively and graft material stability and to
examine the possible effect of steroidal or non-steroidal anti-inflammatory drugs on reducing such
membrane thickening immediately post surgery and if different graft material correlate with
different membrane thicknesses post operatively.
For linear graft measurements, in the current study, the shrinkage percentage of (GH) was the
highest compared to (M-D) and (A-P) width for both groups. Interestingly, there was no statistical
29
difference between both groups in the (GH) shrinkage percentage p=0.6261. The mean maximum
bone graft height linear mean reduction percentage at implant site was 15.823 ± 19.521 for group
1 and 15.511 ± 19.835 for group 2. That was equivalent to 2.41 and 1.89 mm for group 1 and group
2 respectively. This is in accordance with results in the literature of 17.75 % reduction equivalent
to 2.63 mm in ABBM graft at 6 months CBCT and 1.77 mm reduction in graft height in a
panoramic study. (Zhang et al. 2019) (Kim et al. 2016) In regard relative surgical and anatomical
factors that could influence graft height (GH) stability, it was found that the reduction in graft bony
height after LWSA was significantly influenced by the width of the sinus floor as well as the angle
between the lateral and medial sinus walls. The reason for this might be the difficulty of completely
raising the membrane in cases with wide sinuses. (Zhang et al. 2019). In the current study
approximate relative sinus area was measured between two lines at the 3 mm and 9 mm distance
from the sinus floor which will correlate mostly with the graft coronal position within the sinus
cavity. (Fig. 8) Utilizing Pearson analysis, the approximate relative sinus width area correlation
with reduction percentage in post-surgical bone graft height showed weak positive correlation
(ve+) in group 1 (Table. 16). That means there was a trend for wider sinuses to show more bone
graft height reduction at the 6 months post-operative. Such finding was not found in group 2. But
interestingly, when evaluating the sinus sites which received >2 implants per sinus ( 2 subjects in
group 1 and 3 subjects in group 2) it seems 90 % of the maximum bone graft shrinkage differences
within the same sinus site can be related to wider sinus. That meant at the implant site with wider
sinus within the same sinus more shrinkage in maximum bone graft height at 6 months was seen
compared to the other implants. This correlation could not be analyzed due to small number of
multiple implants evaluated. In addition to sinus width, it has been proposed that percentage of
vital bone formation after maxillary sinus augmentation is inversely proportional to the sinus BPD
30
(which correlates with sinus width). (Avila et al. 2010) Also, molar sites are expected to have
wider sinus widths compared to premolar sites. The mean sinus width at the usual lower boundary
of lateral window osteotomy (average 2.3 mm from the floor of sinus) was 9.0 (Chan et al. 2014)
In the current study the mean sinus width at the lower boundary was 10 mm at the 3mm distance
from sinus floor.
In the current study, both the maximum bone graft width (M-D) and (A-P) linear reductions were
less than the maximum bone height reduction with no statistical significant difference in any linear
measurement between the two groups.
In regard of how the graft height (GH) shrinkage affected placing implants, the length of 12 mm
was intended in all cases planned implants even with different diameters. In this regard, 73 % of
the implants placed and included in this study were of 12 mm length (19 of 26 total implants) 69.23
% ( 9 of 13 implants) in group 1 and 76.92 % (10 of 13 implants) in group 2. Even with higher
bone graft volume shrinkage % in group 2 (18.06 ± 9.81) compared to (14.87 ± 16.60) in group 1
that didn’t effect on the implant lengths placed in group 2. This can be related to Maximum bone
graft height shrinkage being similar between two groups even with different graft volume
shrinkage percentage. It seems this deference in volume shrinkage didn’t reach to significant level
to affect the maximum graft height at the 6 months CBCT that could effect on the implant planning.
Another factor that was related to LWSA outcomes is lateral window size. A clinical prospective
study by Kawakami et al, in maxillary sinus floor elevations performed by the lateral approach,
the size of the lateral window did not affect the clinical and radiographic outcomes in terms of
obtained sinus floor height. (Kawakami et al. 2019) In the current study, no statistical difference
was found between the group 1 and group 2 in regard of the window area 98.30, 95.30 mm2
respectively. And no statistical difference was found between the window size and bone graft
31
escaping outside the sinus cavity. In the other hand, a negative correlation between window size
area with percentage of vital bone formation in allograft. (Avila et al. 2012) Another factor that
was related to LWSA outcomes is that sites with multiple tooth loss show more contraction in the
sinus than that with a single tooth lost. (Zhang et al. 2019) No such finding was found in the current
study. For the difference outcomes between simultaneous and delayed implant placement with
LWSA, Cricchio et al indicated that placement of implants could help to resist the pressure of
maxillary air and to better maintain the raised area and the volume of the grafts. (Cricchio et al.
2011) However, Mazzocco et al failed to find significant differences in shrinkage of the volume
of the graft between delayed and simultaneous placement of implants. (Mazzocco et al. 2014) In
the current study, only one site received simultaneous implant, so such analysis could not be
evaluated.
In the current study maxillary sinus perforation rate in total sites was 20.83 % (15 % in included
sites only) which is similar to the rate 19.5-25 % reported by others (Pjetursson et al. 2008, Wallace
et al. 2012). One significant factor that have affected the volume stability in the current study is
healing process after 6 months. In both group 1 and group 2, patients with the highest resorption
in graft volume at 6 months (patient 3ULS and 10 in group 1) (with 58% shrinkage and the 2nd
highest resorption 27 % respectively) and from group 2 ( patient 4 URS) (with 33% shrinkage the
highest in the group) all have unhealed lateral window with soft tissue invasion into lateral window
sites. Which indicate that healing is a very important factor in graft volumetric stability.
In the current study, histological analysis indicated the osteoconductivity feature in both groups.
That was evident in the histological presentation of close contact of new vital bone formation with
RBG. A limitation was that histomorphometric analysis was not feasible due to limited sample
numbers per groups. In the literature percentage of vital bone varies between individual studies
32
and different graft material. For allografts and ABBM, vital bone ranged between 20-32 % and
11-38 % respectively. (Avila et al. 2012, Nishimoto et al. 2019, Sehn et al. 2015, Stacchi et al.
2017)
Over all implants placed with LWSA have high success rate (Pjetursson et al. 2008, Raghoebar
et al. 2019, Kim et al 2019, Nkenke et al. 2009). In the current study all implants were placed
with primary stability achieved in all of the implants 6 months post sinus augmentation.
Within the limitations of the current study is relatively small sample number. From the statistics
part the non-parametric Wilcoxon rank sum test was chosen to accommodate the relatively small
sample size. However, an initial comparison of the non-parametric and mixed model showed that
the results were relative similar. Another limitation is that histomorphometric analysis was not
performed due to limited biopsy sample.
33
CHAPTER V
SUMMARY
In conclusion, within the limitations of this study, results show that both anorganic bovine bone
mineral (ABBM) alone or in combination with mineralized cortical allograft (ABBM + MA)
utilized in LWSA showed good stability and were comparable in regard to volumetric and linear
dimensions stability after 6 months. Future studies with larger sample sizes would be beneficial
to confirm findings regarding effects of sinus membrane thickness and sinus width on LWSA
outcomes.
34
TABLES
35
Table. 1. Schedule of events
36
Table. 2-1 Patients characteristics and implant size
Demographic
Group 1
Patient # Gender Age Smoking Implant site Implant size
#
801 ULS Male 68 No 12 4.6x12

14 4.6x12
15 4.6x10.5
803 URS Male 69 No 2 4.6x12
803 ULS 14 4.6x10.5
804 ULS Male 57 No 14 4.6x12
805 ULS Male 62 No 14 4.6x12
807 ULS Female 69 No 14 4.6x10.5
810 URS Female 66 No 3 4.6x10.5
4 3.8x12
817 URS Male 69 No 3 4.6x12
818 URS Male 61 No 3 4.6x12
819 ULS Male 29 No 15 4.6x12
Group 2
801 URS Male 68 No 3 4.6x12
5 4.6x12
802 URS Female 21 No 4 3.8x12
804 URS Male 57 No 3 4.6x9
806 URS Female 41 No 3 4.6x10.5
808 ULS Female 58 No 14 4.6x12
812 ULS Female 56 No 14 4.6x10.5
15 4.6x12
813 ULS Male 54 No 14 4.6x12
814 URS Female 64 No 3 4.6x12
815 ULS Male 68 No 13 4.2x12
14 4.6x12
817 ULS Male 69 No 14 4.6x12
37
Table. 2-2 Demographic and pre-surgical variables per sinus stratified by randomization
group
Randomization Group
Overall Group 1 Group 2

(N= 20) (N= 10) (N= 10)
Demographics
Gender Female 7 (35%) 2 (20%) 5 (50%)
Male 13 (65%) 8 (80%) 5 (50%)
Age <60 years 8 (40%) 2 (20%) 6 (60%)
>=60 years 12 (60%) 8 (80%) 4 (40%)
Smoking No 20 (100%) 10 (100%) 10 (100%)
Pre-surgery
Tooth bounded No 13 (65%) 7 (70%) 6 (60%)
Yes 7 (35%) 3 (30%) 4 (40%)
Septa present No 6 (30%) 2 (20%) 4 (40%)
Yes 14 (70%) 8 (80%) 6 (60%)
Pre-surgical bone height (mm) Number of observations 20 10 10
Mean 4.83 4.62 5.04
StdDev 2.08 1.70 2.48
Median 4.89 4.51 5.32
IQR 3.845 - 6.5125 4.04 - 5.34 3.07 - 7
Min, Max 1.11 ,8.51 1.11 ,7.56 1.28 ,8.51
Pre-surgical bone thickness (mm) Number of observations 20 10 10
Mean 9.34 8.91 9.77
StdDev 2.05 1.97 2.14
Median 9.33 9.03 9.78
IQR 7.74 - 10.11 8.52 - 11.37
Min, Max 5.86 ,12.67 6.16 ,12.67 5.86 ,12.67
Pre-surgical sinus area (mm3) Number of observations 20 10 10
Mean 74.88 69.67 80.08
StdDev 14.66 13.49 14.55
Median 76.74 70.08 81.57
IQR 63.735 - 85.185 58.98 - 82.29 68.49 - 86.085
Min, Max 46.665 ,106.71 46.665 ,85.98 59.52 ,106.71
Pre-surgical sinus membrane thickness Number of observations 20 10 10
Mean 2.17 2.90 1.43
StdDev 3.13 4.15 1.52
Median 0.78 1.28 0.52
IQR 0.325 - 2.1025 0.33 - 1.96 0.32 - 2.205
Min, Max 0.19 ,10.74 0.19 ,10.74 0.2 ,4.32
38
Table. 3. CBCT pre-surgery measurements per implant
Pre
Group 1
Patien Impla Tooth Bone Sinus width (mm) Approxi Bone Sinus membrane Sin
t# nt # bound height 3 mm 6 mm 9 mm mate thickne thickness (mm) us
ed (Ho)(m relative ss (mm) sept
m) sinus area a
(mm²)
12 No 7.5 10.48 13.44 11.38 65.58 7.15 13.4 Yes
1 ULS 14 No 1.24 12.51 19.25 23.34 107.55 6.8 16.36
15 No 4.84 11.34 16.08 16.93 84.81 9.82 2.04
3 URS 2 No 4.49 8.72 11.28 12.57 63.87 8.79 0.33 Yes
3 ULS 14 No 1.11 9.12 13.08 16.61 77.19 7.74 0.29 Yes
4 ULS 14 Yes 4.17 9.75 13.88 15.68 76.29 9.38 1.84 Yes
5 ULS 14 No 4.04 4.17 13.13 17.03 63.6 12.67 10.74 Yes
7 ULS 14 No 6.28 8.6 10.19 10.36 56.88 9.27 1.01 Yes
10 3 Yes 2.44 8.93 10.35 11.6 61.59 5.8 0.29 Yes
URS 4 Yes 7.59 4.79 5.49 5.79 31.74 6.52 3.63
17 3 No 7.56 9.7 13.82 17.73 82.29 10.65 0.47 No
URS
18 3 Yes 3.65 7.88 10.2 11.78 58.98 6.44 0.19 Yes
URS
19 15 No 5.34 11.09 14.97 17.24 84.99 10.11 1.54 No
ULS
Average (mean): 4.6346 9.0061 12.704 14.464 70.41230 8.54923 4.01
15 54 62 62 769 08
Standard deviation (SD): 2.2187 2.3799 3.3550 4.4393 18.30377 2.01059 5.61371683
11 74 5 27 199 47
Group 2
1 URS 3 No 3.45 14.15 20.12 25.05 117.6 10.54 2 No
5 No 7.8 9.78 12.87 8.41 54.57 8.61 2
2 URS 4 Yes 7 11.87 14.54 15.48 82.05 12.05 0.32 No
4 URS 3 Yes 4.76 8.91 12.24 12.77 65.04 8.52 4.32 Yes
6 URS 3 No 1.31 8.42 11.54 14.41 68.49 5.86 0.2 Yes
8 ULS 14 No 1.28 7.46 7.93 12.38 59.52 7.75 0.29 Yes
12 14 No 7.56 10.38 15.2 18.43 86.43 12.02 0.48 Yes
ULS 15 No 5.93 12.97 15.9 12.28 75.75 10.63 0.48
13 14 No 5.02 9.13 11.86 14.37 70.5 9.99 3.59 Yes
ULS
14 3 Yes 7.06 15.27 17.08 20.3 106.71 12.67 0.38 No
URS
15 13 Yes 12.16 18.12 18.69 18.44 109.68 10.81 0.85 No
ULS 14 Yes 4.86 10.97 13.79 16.44 82.23 11.93 3.56
17 14 No 3.07 11.13 14.28 17.33 85.38 8.56 0.55 Yes
ULS
Average (mean): 5.4815 11.427 14.310 15.853 81.84230 9.99538 1.46307692
38 69 77 08 769 46
Standard deviation (SD): 2.9638 3.0283 3.2274 4.2266 19.52378 2.01823 1.47910663
48 83 36 23 343 61
39
Table. 4. Clinical sinus augmentation surgery measurement
Surgery
Group 1
Patient Graft Lateral Lateral Approximate Lateral
# Sinus amount window window window window
membrane (mm³) length height (mm) dimensions distance
perforation (mm) (AWD) (mm)
(mm²)
1 ULS No 4800 20 7 140 3
3 URS No 2400 15 7 105 5

3 ULS No 4800 11 9 99 4
4 ULS No 2400 9 9 81 4
5 ULS No 2400 17 7 119 8
7 ULS No 1600 9 7 63 8
10 URS No 4000 10 12 120 5
17 URS No 2400 10 8 80 9
18 URS No 2400 7 8 56 7
19 ULS No 2400 10 9 90 5
Average (mean): 3323.077 12.92308 8.384615385 104.076923 5.3076923
Standard deviation 1215.287 4.786466 1.804552647 28.7763257 2.0568834
(SD):
Group 2
1 URS No 3600 17 7 119 4
2 URS Yes 1800 6 9 54 10
4 URS No 3600 10 6 60 5
6 URS Yes 1800 21 7 147 3
8 ULS No 1800 12 10 120 3
12 ULS No 3600 13 7 91 7
13 ULS No 3600 15 9 135 8
14 URS No 3600 13 9 117 8
15 ULS No 1800 10 8 80 5
17 ULS Yes 3600 10 9 90 6
Average (mean): 2907.692 12.84615 7.923076923 100.230769 5.7692308
Standard deviation 911.4654 3.933746 1.187542172 28.3171145 2.1273554
(SD):
40
Table. 5. Max bone graft height per implant
Max bone height after 2 weeks & 6 months

Group 1
Patient # Max bone height Max bone height Max bone height
(mm) (After 2 weeks) (mm) (After6 shrinkage
months) percentage %
1 ULS # 12 12.47 11.9 4.570970329

1 ULS # 14 23.61 15.34 35.02753071
1 ULS # 15 15.13 6.09 59.74884336
3 URS # 2 7.14 6.69 6.302521008
3 ULS # 14 15.51 8.22 47.00193424
4 ULS # 14 9.14 9.73 -6.455142232
5 ULS # 14 10.22 8.93 12.6223092
7 ULS # 14 7.5 7.18 4.266666667
10 URS # 3 12.17 9.81 19.39194741
10 URS # 4 6.93 6.34 8.513708514
17 URS # 3 10.98 10.03 8.652094718
18 URS # 3 12.86 12.41 3.499222395
19 ULS # 15 8.96 8.73 2.566964286
Average (mean): 11.74 9.338461538 15.82381312
Standard deviation (SD): 4.548114994 2.675082074 19.52126876
Group 2
1 URS # 3 20.64 15.34 25.67829457
1 URS # 5 8.31 7.49 9.867629362
2 URS # 4 8.33 6.42 22.92917167
4 URS # 3 11.5 4.83 58
6 URS # 3 13.52 8.96 33.72781065
8 ULS # 14 13.16 12.79 2.811550152
12 ULS # 14 10.47 7.62 27.22063037
12 ULS # 15 10.99 9.52 13.37579618
13 ULS # 14 16.96 15.39 9.257075472
14 URS # 3 10.17 12.76 -25.46705998
15 ULS # 13 6.13 4.93 19.57585644
15 ULS # 14 9.68 9.66 0.20661157
17 ULS # 14 10.51 10.04 4.471931494
Average (mean): 11.56692308 9.673076923 15.511946
41
Table. 6. Bone graft height between-group and within group comparisons
Comparison Randomization group P-value
Between group
Pre-surgical between-group differencea . 0.4417
Post-surgical 2 week between-group differencea . 0.9387
Post-surgical 6 month between-group differencea . 0.7583
% shrinkage in bone height between-group differencesa . 0.6261
Within group
Change in bone height from 2wks to 6mos: within group differencesb Group 1: Bovine only 0.0253
Group 2: Bovine + Allograft 0.0166

a
Wilcoxon rank sum test
b
Paired T-test
42
Table. 7. Maximum bone graft width at implant site (M-D)
Max bone graft width (M-D) after 2 weeks & 6 months

Group 1
Patient # Max bone graft width Max bone graft Max bone graft
(M-D)(mm) (After 2 width (M-D)(mm) width (M-D)
weeks) (After 6 months) shrinkage
percentage %
1 ULS # 12 7.73 9.38 -21.3454075
1 ULS # 14 11.27 18.45 -63.70896185
1 ULS # 15 13.39 8.78 34.42867812
3 URS # 2 8.89 9.19 -3.374578178
3 ULS # 14 12.74 8.4 34.06593407
4 ULS # 14 16.87 12.51 25.84469472
5 ULS # 14 10.5 12.26 -16.76190476
7 ULS # 14 10.63 9.35 12.04139229
10 URS # 3 12.41 5.19 58.17888799
10 URS # 4 6.24 7.24 -16.02564103
17 URS # 3 12.63 12.15 3.800475059
18 URS # 3 11.51 9.76 15.20417029
19 ULS # 15 13.92 12.75 8.405172414
Average (mean): 11.44076923 10.41615385 5.442531664
Group 2
1 URS # 3 21.79 21.65 0.642496558
1 URS # 5 7.6 9.41 -23.81578947
2 URS # 4 6.06 4.78 21.12211221
4 URS # 3 11.25 5.31 52.8
6 URS # 3 12.08 9.39 22.26821192
8 ULS # 14 15.73 14.03 10.80737444
12 ULS # 14 7.76 8.46 -9.020618557
12 ULS # 15 11.39 11.32 0.614574188
13 ULS # 14 12.79 12.05 5.785770133
14 URS # 3 11.76 15.04 -27.89115646
15 ULS # 13 12.37 10.47 15.35974131
15 ULS # 14 16.63 16.57 0.360793746
17 ULS # 14 13.53 13.29 1.77383592
Average (mean): 12.36461538 11.67461538 5.446718918
43
Table. 8. Maximum bone graft width at sinus site (A-P)
Max bone graft width (A-P) after 2 weeks & 6 months

Group 1
Patient # Max bone graft Max bone graft Max bone graft
width (A-P)(mm) width (A-P)(mm) width (A-P)
after 2 weeks after 6 months shrinkage
percentage %
1 ULS 32.75 25.22 22.99236641

3 URS 20.08 20.98 -4.482071713
3 ULS 21.22 21.19 0.14137606
4 ULS 16.76 16.45 1.849642005
5 ULS 18.18 15.7 13.64136414
7 ULS 8.37 14.12 -68.69772999
10 URS 19.1 17.98 5.863874346
17 URS 13.74 13.58 1.164483261
18 URS 15.8 15.18 3.924050633
19 ULS 25.54 27.11 -6.147220047
Average (mean): 21.24153846 19.68692308 1.699903252
Group 2
1 URS 28.34 23.68 16.44318984
2 URS 16.24 15.89 2.155172414
4 URS 18.04 13.51 25.11086475
6 URS 20.31 19.58 3.594288528
8 ULS 15.6 13.61 12.75641026
12 ULS 16.29 21.1 -29.52731737
13 ULS 19.86 18.41 7.301107754
14 URS 22.36 24.23 -8.363148479
15 ULS 15.39 13.08 15.00974659
17 ULS 19.98 17.38 13.01301301
Average (mean): 19.41769231 18.33307692 4.57068818
44
Table. 9. Membrane thickness
Sinus membrane thickness pre, after 2 weeks and after 6 months
Group 1 ( At sinus site )
Patient # Sinus membrane Sinus membrane Sinus membrane
thickness (mm), Pre thickness (mm) thickness (mm)
after 2 weeks after 6 months
1 ULS 10.6 16.07666667 3.253333333

3 URS 0.33 17.14 2.05
3 ULS 0.29 18.4 0.61
4 ULS 1.84 9.45 2.16
5 ULS 10.74 11.92 1.46
7 ULS 1.01 19.3 1.41
10 URS 1.96 4.11 2.035
17 URS 0.47 5.03 0.52
18 URS 0.19 13.52 0.62
19 ULS 1.54 1.04 0.72
Average (mean): 2.897 11.59866667 1.483833333
Group 2 ( At sinus site )
1 URS 2 2.58 4.38
2 URS 0.32 13.07 0.7
4 URS 4.32 20.05 9.23
6 URS 0.2 5.67 16.81
8 ULS 0.29 1.08 0.82
12 ULS 0.48 5.265 1.325
13 ULS 3.59 2.56 0.59
14 URS 0.38 0.69 0.37
15 ULS 2.205 2.62 0.96
17 ULS 0.55 17.78 1.15
Average (mean): 1.4335 7.1365 3.6335
45
Table. 10. Membrane thickness between-group and within group comparisons
Between group
Pre-surgical between-group differencea . 0.5899

a
Post-surgical 6 month between-group difference . 0.9387
% shrinkage in sinus membrane thickness between-group differencesa . 0.0545
Within group
Change in sinus membrane thickness from 2wks to 6mos: within group differencesb Group 1: Bovine only 0.0002
a
b
Paired T-test
46
Table. 11. Graft volume
Graft volume after 2 weeks & 6 months

Group 1
Patient # Graft volume (mm³) Graft volume (mm³) Graft volume
percentage %
1 ULS 4045 3780 6.551297899

3 URS 1483 1337 9.844908968
3 ULS 3169 1324 58.22025876
4 ULS 1794 1570 12.48606466
5 ULS 1314 1206 8.219178082
7 ULS 381.9 373.5 2.199528672
10 URS 2262 1647 27.18832891
17 URS 898.6 837.3 6.82172268
18 URS 1427 1320 7.498248073
19 ULS 2731 2466 9.703405346
Average (mean): 1950.55 1586.08 14.8732942
Group 2
1 URS 4924 4609 6.397238018
2 URS 1001 787.5 21.32867133
4 URS 1388 918 33.86167147
6 URS 1487 1169 21.38533961
8 ULS 1779 1509 15.17706577
12 ULS 2223 2065 7.107512371
13 ULS 3506 2778 20.76440388
14 URS 3586 2831 21.05409927
15 ULS 1794 1717 4.292084727
17 ULS 1943 1374 29.28461143
Average (mean): 2363.1 1975.75 18.06526979
47
Table. 12. Graft volume between-group and within group comparisons
Between group
Post-surgical 6 month between-group differencea . 0.4057
% shrinkage in graft volume between-group differencesa . 0.3258
Within group
Change in graft volume from 2wks to 6mos: within group differencesb Group 1: Bovine only 0.0644

a
b
Paired T-test
48
Table. 13. Void volume
Void volume after 2 weeks & 6 months

Group 1
Patient # Void volume (mm³) Void volume (mm³) Void volume
percentage %
1 ULS 2605 405.2 84.4452975

3 ULS 30.21 64.86 -114.6971202
4 ULS 456.5 36.42 92.02190581
10 URS 85.55 0 100
17 URS 72.32 32.9 54.50774336
19 ULS 738.2 150.5 79.61257112
Average (mean): 664.63 114.98 49.31506627
Group 2
1 URS 823.6 0 100
4 URS 85.74 0 100
6 URS 81.34 0 100
12 ULS 166.6 41.04 75.36614646
13 ULS 90.65 14.92 83.54109211
14 URS 284.3 108 62.0119592
15 ULS 251.5 65.81 73.83300199
17 ULS 72.87 0 100
Average (mean): 232.075 28.72125 86.84402497
49
Table. 14. Graft volume outside sinus
Graft volume out sinus after 2 weeks & 6 months

Group 1
Patient # Graft volume out Graft volume out Graft volume out
sinus (mm³) after 2 sinus (mm³) after 6 sinus shrinkage
weeks months percentage %
1 ULS 447.4 244.4 45.37326777

3 URS 369.9 349.1 5.62314139
3 ULS 38.14 0 100
4 ULS 132.7 68.26 48.56066315
7 ULS 837.1 639.2 23.64114204
Average (mean): 365.048 260.192 44.63964287
Group 2
1 URS 13.18 0 100
4 URS 128.6 30.36 76.39191291
12 ULS 71.4 0 100
13 ULS 0 7.624
15 ULS 323.2 69.37 78.5365099
17 ULS* 1044 0 100
Average (mean): 263.3966667 17.89233333 90.98568456
*17 ULS the graft escaped into sinus space through undetected perforation
50
Table. 15. Comparison of membrane thickness at 2 weeks between those who did and did
not have bone graft outside sinus in group 1
Presence of graft
outside
Statistic No Yes P-valuea
Post-surgical 2-week membrane thickness Number of 5 5 0.0283

observations
Mean 7.344 15.636
StdDev 5.214 4.020
Median 5.210 17.140
Min, Max 1.040, 9.450,

13.52 19.30
% shrinkage in membrane thickness between 2wks and Number of 5 5 0.6015

6mos observations
Mean 0.755 0.806
StdDev 0.262 0.194
Median 0.878 0.880
Min, Max 0.308, 0.485,

0.954 0.967
a
Table. 16. Pearson correlation between pre-surgical sinus area and % shrinkage in post-
surgical bone height
Correlation
w/ approx
Randomization group Measurement sinus area Papprox_sinus_area
Group 1: Bovine only % shrinkage in maximum bone height over time 0.42785 0.1447
Group 2: Bovine + Allograft % shrinkage in maximum bone height over time -0.20827 0.4947
51
FIGURES
52
Figure. 1. Study outline and sequence of events
53
Figure. 2. Study outline and sequence of events
54
A
Figure. 3. Intraoperative lateral view of bone graft inside lifted maxillary sinus cavity : (A)
group 1; (B) group 2
A B
55
Figure. 4. lateral window sites were covered by a resorbable collagen membrane (Mem-
lokÒ, Biohorizons, USA) to completely cover the window
Figure. 5. Primary closure after sinus augmentation surgery
56
A B
Figure. 6. Lateral Window Dimensions : (A) Window height at middle of window; (B)
Window length at middle of window; (C) Window distance from the bone crest
57
Figure. 7. STL file image of pre-operative planning for implant positions. The pre-
operative STL for each patient was superimposed over the 2w and 6m CBCTs to replicate
the exact implant positions
58
Figure. 8. Pre-operative CBCT linear measurements: (A) Sinus width (mm) (at 3
points; at 3mm, 6mm, 9mm above sinus floor); (B) Residual bone height (mm); (C)
Residual bone thickness (mm); (D) Sinus membrane thickness; (ARSWA) Approximate
relative sinus width area
59
B A
Figure. 9. (A) 2 weeks and (B) 6 months CBCT linear measurements: (GH1) Maximum
bone graft height excluding residual bone (mm) at 2 weeks (GH2) at 6 months; (GMD1)
Maximum bone graft width (Mesial-Distal) (mm) at 2 weeks (GMD2) at 6 months; (T1)
sinus membrane thickness at 2 weeks (T2) at 6 months
60
Figure. 10. (GAP1) Maximum bone graft width (Anterior-Posterior) (mm) at 2 weeks
CBCT and (GAP2) at 6 months CBCT
61
Figure. 11. Maxillary sinus bone graft 3D volumetric analysis using ITK-SNAP with
different cross sectional presentation (Red color) bone graft (Green color) void. (S)
Sagittal (S2) Sagittal with no color mapping of the bone graft (C) Coronal (A) Axial
(G3D) 3D rendering of the bone graft (G3D2) notice opacity of the colors of the graft
can be changed to visualize in this case the void and bone graft
62
Maximum bone graft height
(Group 1)
Max bone height (mm) (After 2 weeks) Max bone height (mm) (After6 months)
Maximum bone graft height (mm)
23.61
25
15.51
15.34
15.13
20
12.86
12.47
12.41
12.17
10.98
11.9
10.22
10.03
15
9.81
9.73
9.14
8.93
8.96
8.73
8.22
7.18
7.14
6.93
6.69
6.34
7.5
6.09
10
5
0
0
0
1ULS 1ULS 1ULS 3URS #2 3ULS 4ULS 5ULS 7ULS 10URS 10URS 17URS 18URS 19ULS
#12 #14 #15 #14 #14 #14 #14 #3 #4 #3 #3 #15
Figure. 12. Maximum bone graft height group 1 per implant
Maximum bone graft height

(Group 2)
Max bone height (mm) (After 2 weeks) Max bone height (mm) (After6 months)
Maximum bone graft height ((mm)
20.64
25
16.96
15.39
15.34
20
13.52
13.16
12.79
12.76
10.99
10.47
10.51
11.5
10.17
10.04
15
9.68
9.66
9.52
8.96
8.31
8.33
7.62
7.49
6.42
6.13
10
4.93
4.83
5
0
1URS #3 1URS #5 2URS #4 4URS #3 6URS #3 8ULS 12ULS 12ULS 13ULS 14URS 15ULS 15ULS 17ULS
#14 #14 #15 #14 #3 #13 #14 #14
Figure. 13. Maximum bone graft height group 2 per implant
Average shrinkage of max bone height percentage:

20
15.82381312 15.511946
15
Percentage %
10
0
Group 1 Group 2
Figure. 14. Maximum bone graft shrinkage between groups
63
Maximum bone graft width (M-D)
Maximum bone graft width (m-d) (mm)
(Group 1)
Max bone graft width (M-D)(mm) (After 2 weeks) Max bone graft width (M-D)(mm) (After 6 months)
18.45
16.87
20
13.92
13.39
12.74
12.75
12.63
12.51
12.41
12.26
12.15
11.51
11.27
10.63
15
10.5
9.76
9.38
9.35
9.19
8.89
8.78
7.73
8.4
7.24
6.24
10
5.19
5
0
1ULS 1ULS 1ULS 3URS #2 3ULS 4ULS 5ULS 7ULS 10URS 10URS 17URS 18URS 19ULS
#12 #14 #15 #14 #14 #14 #14 #3 #4 #3 #3 #15
Figure. 15. Maximum bone graft width (M-D) group 1 per implant
Maximum bone graft width (M-D)

(Group 2)
Maximum bone graft width (m-d) (mm)
Max bone graft width (M-D)(mm) (After 2 weeks) Max bone graft width (M-D)(mm) (After 6 months)
21.79
21.65
25
16.63
16.57
15.73
15.04
14.03
13.53
20
13.29
12.79
12.37
12.08
12.05
11.76
11.39
11.32
11.25
10.47
15
9.41
9.39
8.46
7.76
7.6
6.06
5.31
10
4.78
5
0
1URS #3 1URS #5 2URS #4 4URS #3 6URS #3 8ULS 12ULS 12ULS 13ULS 14URS 15ULS 15ULS 17ULS
#14 #14 #15 #14 #3 #13 #14 #14
Figure. 16. Maximum bone graft width (M-D) group 2 per implant
Average shrinkage of max bone graft width (M-D) percentage:

20
15
Percentage %
10
5.442531664 5.446718918
5
0
Group 1 Group 2
Figure. 17. Maximum bone graft width (M-D) shrinkage between groups
64
Average shrinkage of max bone graft width (A-P) percentage:
6
4.57068818
4
Percentage %
2 1.699903252
0
Group 1 Group 2
Figure. 18. Maximum bone graft width (A-P) shrinkage between groups
65
Graft volume (mm³)
(Group 1)
Figure. 20. Graft volume (mm³) after 2 weeks Graft volume (mm³) after 6 months
4045
Graft volume (mm³)
5000
3780
3169
4000
2731
2466
2262
3000
1794
1647
1570
1483
1427
1337
1324
1314
1320
1206
898.6
837.3
2000
381.9
373.5
1000
0
1 ULS 3 URS 3 ULS 4 ULS 5 ULS 7 ULS 10 URS 17 URS 18 URS 19 ULS
Figure. 19. Graft volume at 2 weeks and 6 months in group 1
Graft volume (mm³)

(Group 2)
Graft volume (mm³) after 2 weeks Graft volume (mm³) after 6 months
4924
Graft volume (mm³)
6000
4609
5000
3586
3506
4000
2831
2778
2223
2065
1943
3000
1794
1779
1717
1509
1487
1388
1374
1169
1001
787.5
2000
918
1000
0
1 URS 2 URS 4 URS 6 URS 8 ULS 12 ULS 13 ULS 14 URS 15 ULS 17 ULS
Figure. 20. Graft volume at 2 weeks and 6 months in group 2
Average shrinkage of graft volume percentage:

20 18.06526979
14.8732942
15
Percentage %
10
0
Group 1 Group 2
Figure. 21. Graft volume shrinkage between groups
66
Void volume (mm³)
Figure. 23. (Group 1)
Void volume (mm³) after 2 weeks Void volume (mm³) after 6 months
2605
3000
Void volume (mm³)
2500
2000
1500
738.2
456.5
405.2
1000
150.5
85.55
72.32
64.86
36.42
30.21
32.9
500
0
0
1 ULS 3 ULS 4 ULS 10 URS 17 URS 19 ULS
Figure. 22. Void volume at 2 weeks and 6 months in group 1
Void volume (mm³)

(group 2)
Void volume (mm³) after 2 weeks Void volume (mm³) after 6 months
823.6
1000
Void volume (mm³)
800
600
284.3
251.5
400
166.6
90.65
85.74
81.34
72.87
65.81
41.04
108
14.92
200
0
0
0
1 URS 4 URS 6 URS 12 ULS 13 ULS 14 URS 15 ULS 17 ULS
Figure. 23. Void volume at 2 weeks and 6 months in group 2
Average shrinkage of void volume percentage:

100
86.84402497
90
80
70
Percentage %
60
49.31506627
50
40
30
20
10
0
Group 1 Group 2
Figure. 24. Void volume shrinkage between groups
67
Fig. 25. Bone graft outside sinus cavity at (C) coronal cross section with and without color
mapping (S) sagittal cross section
68
Graft volume outside sinus (mm³)
(group 1)
Graft volume out sinus (mm³)
Graft volume out sinus (mm³) after 2 weeks Graft volume out sinus (mm³) after 6 months
837.1
1000
639.2
800
447.4
369.9
600
349.1
244.4
400
132.7
68.26
38.14
200
0
0
1 ULS 3 URS 3 ULS 4 ULS 7 ULS
Figure. 26. Graft volume outside sinus at weeks and 6 months in group 1

(group 2)
Graft volume out sinus (mm³) after 2 weeks Graft volume out sinus (mm³) after 6 months
1500
1044
1000
323.2
128.6
69.37
30.36
13.18
7.624
500
71.4
0
0
0
1 URS 4 URS 12 ULS 13 ULS 15 ULS 17 ULS
*17 ULS bone graft escaped into sinus cavity through undetected perforation
Figure. 27. Graft volume outside sinus at weeks and 6 months in group 2
Average shrinkage of graft volume out sinus percentage:

100 90.98568456
90
80
70
Percentage %
60
50 44.63964287
40
30
20
10
0
Group 1 Group 2
Figure. 28. Graft volume outside sinus shrinkage in two groups
69
Figure. 29. (A) Histologic section of one of the samples of group 1 obtained after sagittal
section of a bone core biopsy (H&E, original magnification ×2). Two images (B) at a higher
magnification Note the presence of VB in intimate contact with RBG black arrow (H&E,
original magnification ×20). (C) polarized representation note the vital bone shows the
polarization. (D) Newly formed VB over RBG particles with an NMT matrix. Note the
osteocytes in the lacunae (green arrow) (H&E, original magnification ×40).
70
Figure. 30. (A) Histologic section of one of the samples of group 2 obtained after sagittal
section of a bone core biopsy. Note the limited non mineralized tissue (H&E, original
magnification ×2). (B) Polarized representation note the vital bone shows the polarization
(C) Image at a higher magnification. Note the presence of VB in intimate contact with RBG
Note the osteocytes in the lacunae (green arrow) (H&E, original magnification ×40).
71
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staged augmentation of the sinus floor, and an analysis of influential factors. British Journal
of Oral and Maxillofacial Surgery, Volume 57, Issue 4, 2019, 323 – 329
76

Volumetric Changes and Graft S

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Volumetric Changes and Graft S

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THE UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER

VOLUMETRIC CHANGES AND GRAFT STABILITY IN LATERAL WINDOW SINUS

AUGMENTATION: A PROSPECTIVE CLINICAL TRIAL

SUBMITTED TO THE GRADUATE FACULTY

in partial fulfillment of the requirements for the

Oklahoma City, Oklahoma

All rights reserved

INFORMATION TO ALL USERS

All Rights Reserved.

Periodontics department of the University of Oklahoma for their constant help.

LIST OF TABLES .......................................................................................................5

LIST OF FIGURES .....................................................................................................6

I. INTRODUCTION AND LITERATURE REVIEW ...................................... 10

II. MATERIALS AND METHODS ................................................................... 13

III. RESULTS ....................................................................................................... 21

IV. DISCUSSION ................................................................................................. 26

2. Patients characteristics and implant size......................................................... 37

3. Demographic and pre-surgical variables per sinus stratified by

4. CBCT pre-surgery measurements per implant …………………………...…. 39

5. Clinical sinus augmentation surgery measurement …………………………. 40

6. Maximum bone graft height per implant…………………............................. 41

7. Bone graft height between-group and within group comparisons ………....... 42

8. Maximum bone graft width at implant site (M-D) ………………………….. 43

9. Maximum bone graft width at sinus site (A-P) ……………………………… 44

10. Membrane thickness …………………………………………………………. 45

12. Graft volume …………………………………………………………………. 47

13. Graft volume between-group and within group comparisons ………………. 48

14. Void volume …………………………………………………………………. 49

15. Graft volume outside sinus ………………………………………………….. 50

did not have bone graft outside sinus in group 1 ..…………………………… 51

17. Pearson correlation between pre-surgical sinus area and % shrinkage

in post-surgical bone height….…………………………………………………… 51

1. Study outline and sequence of events ……………………………………..... 53

2. Study outline and sequence of events ………………………………………. 54

4. lateral window sites were covered by a resorbable collagen membrane ……. 56

5. Primary closure after sinus augmentation surgery …………………………... 56

6. Lateral Window Dimensions ………………………………………………... 57

7. STL file image of pre-operative planning for implant positions ……………. 58

8. Pre-operative CBCT linear measurements ………………………………….. 59

9. 2 weeks and 6 months CBCT linear measurements ………………………… 60

10. (GAP1) Maximum bone graft width (Anterior-Posterior) (mm) at

2 weeks CBCT and (GAP2) at 6 months CBCT..………………….……………. 61

11. Maxillary sinus bone graft 3D volumetric analysis using ITK-SNAP

with different cross sectional presentation……………….……………….….. 62

12. Maximum bone graft height group 1 per implant …………………………… 63

13. Maximum bone graft height group 2 per implant …………………………… 63

14. Maximum bone graft shrinkage between groups ……………………………. 63

19. Graft volume at 2 weeks and 6 months in group 1 ………………….……..… 66

20. Graft volume at 2 weeks and 6 months in group 2 ………………………… 66

21. Graft volume shrinkage between groups ………………………………..…. 66

22. Void volume at 2 weeks and 6 months in group 1 …………………………. 67

23. Void volume at 2 weeks and 6 months in group 2 …………………………. 67

24. Void volume shrinkage between groups ………………………………...…. 67

and without color mapping (S) sagittal cross section………………………. 68

28. Graft volume outside sinus shrinkage in two groups ………………………. 69

29. Histologic section of one of the samples of group 1 ……………………….. 70

30. Histologic section of one of the samples of group 2 ……………………….. 71

performed of the augmented site.

obtained after 6 months at time of implant placement for histological analysis.

have an effect on sinus augmentation outcomes.

and demineralized allograft showed 19.38±9.2 %, 24.66±4.68 shrinkage at 6 months respectively

aimed at evaluating percentage of graft volume reduction, no statistically significant difference

presentation of xenograft alone to a combination of xenograft and allograft showed high

no significant difference in volumetric changes of graft material in sinus augmentation procedure