YIJOM-4526; No of Pages 8

Int. J. Oral Maxillofac. Surg. 2019; xxx: xxx–xxx

https://doi.org/10.1016/j.ijom.2020.08.015, available online at https://www.sciencedirect.com

Randomised Clinical Trial

Dental Implants

Immediate dental implant B. M. Naji1, S. S. Abdelsameaa1,

A. Y. Alqutaibi2,3, W. M. Said Ahmed1
1
Department of Oral and Maxillofacial

placement with a horizontal gap Surgery, Faculty of Dentistry, Mansoura

University, Mansoura, Egypt; 2Prosthodontics
Department, College of Dentistry, Taibah
University, Al Madinah Al Munawwarah, Saudi

more than two millimetres: a Arabia; 3Prosthodontics Department, College

of Dentistry, Ibb University, Ibb, Yemen

randomized clinical trial

B. M. Naji, S. S. Abdelsameaa, A. Y. Alqutaibi, W. M. Said Ahmed: Immediate dental
implant placement with a horizontal gap more than two millimetres: a randomized
clinical trial. Int. J. Oral Maxillofac. Surg. 2019; xxx: xxx–xxx. ã 2020 International
Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights
reserved.

Abstract. The purpose of this study was to evaluate the horizontal dimensional
changes in buccal alveolar bone immediately after dental implant placement in the
upper premolar area with horizontal gaps >2 mm. A total of 48 patients were
enrolled in this randomized clinical trial and were randomly assigned to one of three
groups. Group I (flap with graft; n = 16) patients received an immediate implant
with bone graft, membrane, and primary flap closure. Group II (flap without graft; n
= 16) patients received an immediate implant with primary flap closure only. Group
III (flapless without graft; n = 16) patients received an immediate implant without
graft, membrane, or primary closure. Cone beam computed tomography (CBCT)
scans were obtained preoperatively, immediately after implant placement, and at 6
months postoperative to evaluate horizontal dimensional changes in the buccal
alveolar bone. Pain intensity was measured using a numerical rating scale. CBCT
examinations revealed that bone had filled the horizontal gap in all three groups.
Group II showed the greatest horizontal dimensional changes in the buccal alveolar
bone, followed by group I. The least amount of change was recorded for group III.
Key words: immediate dental implant; horizon-
Furthermore, significantly less postoperative pain was recorded in group III when tal gap; buccal bone; primary flap closure;
compared to the other groups. Short-term results suggest that the ‘flapless without dimensional changes.
graft’ technique shows similar results to the ‘flap with graft technique’ for
immediate implant placement in the maxillary premolar extraction site with a Accepted for publication 28 August 2020
horizontal gap >2 mm, when the bone plate is intact.

Dental implants may be placed into the success rates have been reported using aging the horizontal gap between the
extraction socket immediately after tooth this approach2. However, the surgeon implant surface and the buccal bone plate
removal to shorten the treatment period faces two challenges during immediate formed after fixture placement; and sec-
and increase patient comfort1, and high implant placement: first, effectively man- ond, problematic closure of the primary

0901-5027/000001+08 ã 2020 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Naji BM, et al. Immediate dental implant placement with a horizontal gap more than two millimetres:
a randomized clinical trial, Int J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.ijom.2020.08.015
YIJOM-4526; No of Pages 8
2 Naji et al.
socket due to the opening left by tooth
removal3.
Flap closure is a useful technique in the
immediate implant protocol. While coro-
nal advancement flaps for primary closure
might offer the advantages of preventing
bacterial invasion and preventing wound
disruption4, the approach is traumatic to
the soft tissues and is associated with
postoperative pain and swelling5. Many
authors have advocated flap elevation
for primary closure through suturing6,
whereas others have accomplished flap-
less surgery and allowed healing to occur
via secondary intention7.
The defect between the implant surface
and buccal bone in the horizontal dimen-
sion following implant insertion in a post-
extraction socket will be filled with new
bone, a process associated with dimen-
sional changes in the socket walls due
to marked osteoblastic activity8. While
the gap can occur at any surface of the
immediately placed implant, the buccal
aspect is of particular importance, partic-
ularly in the aesthetic zone (between the
second contralateral premolars), because
the buccal bone is usually thin and has a
high tendency for resorption and resultant
soft tissue recession9,10.
Several treatment options are available
to manage horizontal gaps, reduce buccal
bone resorption, and prevent soft tissue
Fig. 1. (A) Preoperative occlusal view demonstrating an unrestorable premolar before extraction. (B, C, D) Immediately placed implant with a
horizontal critical-sized gap: (B) flap with graft group, (C) flap without graft group, (D) flapless without graft group.
Please cite this article in press as: Naji BM, et al. Immediate dental implant placement with a horizontal gap more than two millimetres:
a randomized clinical trial, Int J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.ijom.2020.08.015
dehiscence, including the application of
graft material with or without membrane,
use of barrier membranes without any
graft, customized healing abutments, pro-
visional restorations to seal the gap with-
out grafts or barrier membranes, and
primary closure11–14.
Gaps of >2 mm located around the
immediately placed implant in the hori-
zontal dimension are sufficiently large to
affect spontaneous bone healing. Howev-
er, in humans, gaps of <2 mm heal spon-
taneously without any regenerative
procedure10. The optimal management
of a horizontal gap of >2 mm is debated,
creating uncertainty around the best tech-
nique to use to ensure bone filling with the
least amount of buccal bone resorption and
soft tissue recession15.
In this study, cone beam computed to-
mography (CBCT) was used to evaluate
the horizontal dimensional changes in
buccal alveolar bone after immediate den-
tal implant placement in the upper premo-
lar area with horizontal gaps >2 mm.
The tested null hypothesis was that
there would be no difference in the hori-
zontal dimensional changes of the buccal
alveolar bone with the following inter-
ventions: primary flap closure with graft-
ing and membrane (flap with graft),
primary flap closure without grafting or
membrane (flap without graft), and flap-
less without grafting, membrane, or pri-
mary closure.
Materials and methods
This prospective, parallel, three-arm ran-
domized clinical study was performed in
accordance with the principles of the Dec-
laration of Helsinki. All procedures were
approved by the Ethics Committee of the
College of Dentistry, Mansoura Universi-
ty (registration number 04060318). This
study is reported according to the CON-
SORT statement16. Written informed con-
sent was obtained from each participant.
The total sample size was calculated
using a two-tailed alpha of 0.05 with a
confidence level of 95% and a power of
80%. Forty-eight patients (16 patients per
group) was calculated to be adequate to
detect the effect size of 0.9  0.8 mm of
horizontal dimensional bone change.
Criteria for inclusion included age 18
years, unrestorable maxillary premolar
tooth, good oral hygiene, favourable oc-
clusion, intact socket walls, a horizontal
gap >2 mm in size, and a buccal bone
plate thickness 1 mm. The following
were excluded: smokers, those with any
local or systemic condition that contra-
indicated dental implant placement, and
pregnant women.
YIJOM-4526; No of Pages 8

Implant placement with horizontal gap 2 mm 3

After preoperative CBCT evaluation,
48 patients requiring immediate dental
implant placement after the extraction of
an upper premolar tooth (Fig. 1A) were
included in the study. These patients were
randomly assigned to one of three study
groups (16 in each group) using a prede-
veloped random sampling list in Excel.
Patients assigned to group I (flap with
graft) received an immediate implant with
bone graft, barrier membrane, and primary
flap closure (Fig. 1B). Patients assigned to
group II (flap without graft) received an
immediate implant only, with primary flap
closure (Fig. 1C), and patients assigned to
group III (flapless without graft) received
an immediate implant without bone graft
or membrane or primary closure (Fig. 1D).
Table 1 shows the baseline characteristics
of the patients included in the three study
groups.
Only one investigator, who was not
involved in the selection or treatment of
the patients, was aware of the randomiza-
tion sequence and had access to the ran-
domization list, which was stored in a
password-protected portable computer.
The randomization codes were placed in
sequentially numbered, identical opaque
sealed envelopes. Patients were asked to
select one of the envelopes, and the inves-
tigator who was aware of the randomiza-
tion process was then asked about the
specific group allocation and the patient
was treated accordingly. Single-blinding
was implemented, with only the outcome
assessor blinded to the intervention. The
radiographic evaluation was performed by
an independent assessor who not aware of
the type of intervention.
Before surgery, the patients were ad-
ministered a prophylactic antibiotic regi-
men (amoxicillin 2 g oral tablet) and
rinsed with 0.2% chlorhexidine gluconate
mouth wash. All surgical interventions
were performed by the same experienced
surgeon. Following the administration of
2% mepivacaine HCL with 1:20,000 levo-
nordephrine as local anaesthesia and once
the tooth had been anesthetized, the ex-
traction was performed with a periotome
and forceps as atraumatically as possible
to preserve the bony socket walls. Once
the tooth had been delivered from the
socket, the socket was meticulously deb-
rided and curetted to remove any soft
tissue remnants and checked for the integ-
rity of its four walls. If the buccal bone
was fractured during the extraction, the
patient was excluded from the study.
The implant site was prepared with
drills according to the manufacturer’s
instructions, under controlled torque and
speed. The drilling extended apically 3–4
mm within the native apical bone to
achieve primary stability. After drilling
with the final implant drill, the sealed
sterile implant package was opened, and
the implant was introduced into the pre-
pared osteotomy site with a manual ratchet
(40 Ncm of torque). The implant shoulders
were located 1 mm subcrestal to the buc-
cal bone. The implants used in this study
were conventional threaded two-piece ta-
pered screw-type titanium dental implants
with an SLA surface (Neo Biotech, Seoul,
Korea). Following implant placement, the
gap width was measured clinically using a
periodontal probe to ensure a distance of
>2 mm from the buccal bone plate to the
implant surface.
For group I (flap with graft), a full-
thickness mucoperiosteal flap was
reflected with two vertical incisions. The
gap between the buccal bone and the
surface of the implant was then filled with
alloplastic nanocrystalline calcium sul-
phate bone graft (Orthogen LLC, Spring-
field, New Jersey, USA) and covered with
an absorbable collagen membrane (Bioim-
plon GmbH, Gießen, Germany). Further
sub-periosteal incisions were used, and the
flap was advanced to allow for primary
closure, which was accomplished with 4–0
Vicryl suture. The same protocol was
followed for the management of group
II patients (flap without graft), but without
bone graft or membrane. Patients in group
III (flapless without graft) did not have a
flap released, and the horizontal gap was
left to heal without bone graft, barrier
membrane, or primary closure.
Radiographic evaluations were per-
formed using CBCT before tooth extrac-
tion, immediately after implant placement
(T1), and then after 6 months (T2). All
CBCT scans were performed in the same
radiology centre using the same parame-
ters (110 kVp, 24 s, 5.7 mA, and voxel
size 0.2 mm; field of view 6 cm  8 cm),
and all measurements were taken twice by
the same examiner at two different time
points.
From the CBCT image, the following
findings were recorded and evaluated: the
thickness of the buccal bone plate and the
expected width of the horizontal gap, the
distance from the buccal surface of the
implant to the external surface of the
buccal bone (horizontal gap width in ad-
dition to buccal bone plate thickness), with
the reference point 1.5 mm apical to the
crest of the implant (Fig. 2).
Examples of the measurement of the
horizontal dimension of the alveolar buc-
cal bone in the three groups, immediately
after implant placement (T1) and after 6
months (T2), are shown in Figs 3–5.
At 7 days postoperative, the pain inten-
sity was measured using a numerical rat-
ing scale (NRS) ranging from 0 to 10, with
0 denoting no pain and 10 denoting the
worst possible pain.
All values obtained were tabulated and
analysed statistically; a P-value less than
0.05 was regarded as statistically signifi-
cant. Analysis of variance (ANOVA) was
used to compare the values between the
three groups, followed by a post-hoc anal-
ysis (Tukey test) for pairwise compari-
sons. The paired t-test was used to
compare the values between T1 and T2
for each group.

Table 1. Baseline characteristics of the participants included in the three groups. Results
Group I Group II Group III The sample comprised 48 patients (18
Data Flap with graft Flap without graft Flapless without graft male and 30 female) ranging in age from
Sex 28 to 55 years, with an average age of 41.5
Male 5 7 6 years. A total of 52 implants were inserted,
Female 11 9 10 with no implant lost during the 6-month
Age (years), mean 40.2 43.3 41.1 follow-up period. Three patients were ex-
Gingival biotype cluded, two in the flap with graft group
Thin 8 10 7 (group I) and one in the flapless without
Thick 8 6 9 graft group (group III) due to a fracture of
Implant length
the bone plate, so that the total number of
11.5 mm 4 5 7
13 mm 12 11 9 participants analyzed was 45 (14 flap with
Implant diameter (mm) 3.7 3.7 3.7 graft, 16 flap without graft, and 15 flapless
without graft), as shown in Fig. 6.

Please cite this article in press as: Naji BM, et al. Immediate dental implant placement with a horizontal gap more than two millimetres:
a randomized clinical trial, Int J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.ijom.2020.08.015
YIJOM-4526; No of Pages 8

4 Naji et al.

difference (). There were significant dif-

ferences between groups I (flap with graft)
and II (flap without graft) (P = 0.016) and
between groups II (flap without graft) and
III (flapless without graft) (P = 0.003),
whereas no significant difference was
found between group I (flap with graft)
and group III (flapless without graft) (P =
0.744) (Table 2). A bar chart showing the
horizontal dimensional changes in the
three study groups is given in Fig. 7.
The pain intensity was demonstrated to
be significantly higher in the patients in
the flap with graft group (group I), and
there was mild or no pain in the flapless
without graft group (group III) (P <
0.001) (Table 3).

Discussion
Over the last two decades, dental implan-
tology has improved greatly, giving rise to
new opportunities for dental rehabilitation
in cases that were previously considered
unfeasible. This study was conducted to
evaluate the effect of a horizontal gap with
a width >2 mm on dimensional changes in
Fig. 2. CBCT landmarks and measurements: B, implant bevel plane; E, implant vertical plane; the buccal alveolar bone after dental im-
C, point of starting measurement (1.5 mm from the implant bevel plane); D, implant corner plant placement in the upper premolar area
plane; C–A, indicates the measurement of buccal alveolar bone. at 6 months postoperative, following the
use of three approaches: flap graft, flap
without graft, and flapless without graft.
CBCT examinations revealed that bone less without graft), respectively (P = Three participants were excluded from the
had filled the gap in the three study groups. 0.427) (Table 2). analysis, as mentioned above, but they
There was no significant difference in the Regarding the horizontal change in the received a dental implant with a final
study variables between the groups imme- buccal alveolar bone after 6 months (T2), prosthesis.
diately after implant placement; the mean the null hypothesis was rejected. The This study demonstrated that a horizon-
value of the buccal bone plate thickness mean change in the buccal alveolar bone tal gap >2 mm, with a thick intact buccal
plus the horizontal gap width at T1 was in group II (flap without graft) was com- bone around the immediate implant in the
3.56  0.10 mm, 3.71  0.57 mm, and paratively higher than that in group I (flap aesthetic zone, can heal through secondary
3.43  0.33 mm in groups I (flap with with graft) and group III (flapless without intention without any bone graft or mem-
graft), II (flap without graft), and III (flap- graft) at 6 months, with a significant brane. This might be due to the fact that

Fig. 3. Cross-sectional CBCT view of a case in the flap with graft group: (A) immediately after implant placement, (B) 6 months postoperative.

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a randomized clinical trial, Int J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.ijom.2020.08.015
YIJOM-4526; No of Pages 8

Implant placement with horizontal gap 2 mm 5

Fig. 4. Cross-sectional CBCT view of a case in the flap without graft group: (A) immediately after implant placement, (B) 6 months postoperative.

Fig. 5. Cross-sectional CBCT view of a case in the flapless without graft group: (A) immediately after implant placement, (B) 6 months
postoperative.

bone formation around the implant is de-
pendent on the stabilized initially formed
coagulum rather than on the regenerative
materials17. These results are in agreement
with those of Tarnow and Chu12, who
provided histological evidence of osseoin-
tegration on the buccal surface of an im-
plant fixture inserted in the fresh upper
canine socket with a gap distance of
4.2 mm, without a graft or barrier mem-
brane, and left to heal through secondary
intention. They are in disagreement with
the findings reported by Wilson et al.18,
who concluded that a marginal defect
exceeding 1.5 mm revealed incomplete
bone fill without the use of a barrier
membrane.
The results of the present study showed
that bone had completely filled the hori-
zontal gap in all three treatment groups
after 6 months. This indicates that the
presence of a bone graft or any regenera-
tive material has no effect on bone filling
within a gap >2 mm in the presence of a
thick intact buccal bone plate. This finding
conflicts with those of other studies, which
have reported that grafting of the large
buccal gap immediately after implant
placement is recommended to enhance
bone filling within the gap and significant-
ly reduces the horizontal resorption of
buccal bone19,20.
However, the findings of previous stud-
ies could have resulted from the inclusion
of cases with a buccal bone width <1 mm,
some of them with bony fenestration19,20.
It has been advised by several authors that
with a buccal bone plate width of <1 mm
or with fenestration, gap grafting and re-
generation are recommended to enhance
bone filling and reduce the bone
reduction21–23. In the present study, any
case with a buccal bone thickness <1 mm
and any case with fenestration was exclud-
ed during the patient selection and exami-
nation procedures.
The blood supply to the buccal bone
comes from three sources: periodontal
ligament, periosteum, and bone mar-
row24. In this study, the findings revealed
a significant difference between group II
(flap without graft) and group III (flapless
without graft) concerning the horizontal
dimensional changes in the buccal alveo-
lar bone. The resorption of the buccal
alveolar bone width with the flap approach
was greater than that with the flapless
approach, because the flap elevation from
the buccal bone disturbs the periosteum,
which compromises the blood supply and
increases the osteoclastic activity on the
buccal bone surface25. These results are in
agreement with those reported by Vera

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a randomized clinical trial, Int J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.ijom.2020.08.015
YIJOM-4526; No of Pages 8

6 Naji et al.

Fig. 6. CONSORT flowchart of the study.

Fig. 7. Bar chart of the horizontal dimensional changes in the three study groups.

Table 2. Comparison of the horizontal dimension of the buccal alveolar bone (in millimetres) between the three study groups.
P-value
Group I Group II Group III Between the
Flap with graft Flap without graft Flapless without graft three groupsa I vs IIb I vs IIIb II vs IIIb
T1 3.56  0.10 3.71  0.57 3.43  0.33 0.427 0.52 0.81 0.47
T2 3.18  0.05 2.80  0.25 3.19  0.28 0.005* 0.011* 0.99 0.010*
P-valuec <0.001* 0.004* 0.001* – – – –
T2 T1 0.37  0.09 0.91  0.54 0.24  0.11 0.003* 0.016* 0.744 0.003*
T1, immediately after implant placement; T2, 6 months after implant placement.
a
P-value for the comparison between the three groups; analysis of variance (ANOVA).
b
P-value for pairwise comparisons between each of the two groups; Tukey post hoc test.
c
P-value for pairwise comparisons between T1 and T2 for each group; paired t-test.
*
Statistically significant at P  0.05.

Please cite this article in press as: Naji BM, et al. Immediate dental implant placement with a horizontal gap more than two millimetres:
a randomized clinical trial, Int J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.ijom.2020.08.015
YIJOM-4526; No of Pages 8
Table 3. Comparison of the pain intensity on a numerical rating scale (NRS) between the three study groups.
Group I Group II
Flap with graft Flap without graft
5.14  0.69 3.71  0.76
a
P-value for the comparison between the three groups; analysis of variance (ANOVA).
b
P-value for pairwise comparison between each of the two groups; Tukey post hoc test.
*
Statistically significant at P  0.05.
et al.26 and Brownfield et al.27, who con-
firmed that if the flap is not elevated, there
is greater preservation of the buccal alve-
olar bone width from resorption.
In addition, this study confirmed that the
management of a horizontal gap >2 mm
with a bone graft and membrane covered
with a mucoperiosteal flap is better than
management with primary closure in re-
ducing the horizontal ridge resorption,
which might be attributed to the bone
graft. The presence of a barrier membrane
has been shown to enhance new bone
formation and act as a scaffold in gaps
around the implant, which helps limit
dimensional changes during the healing
period28–31. This study found a statisti-
cally significant difference between group
I (flap with graft) and group II (flap with-
out graft). Similar results have been
reported by Botticelli et al.32, who found
that the amount of horizontal bone resorp-
tion was about 56% when no bone was
added to a large-sized gap >3 mm. Re-
garding bone resorption, the present study
showed that the buccal alveolar bone
undergoes resorption after 6 months of
healing, in spite of the presence of a bone
graft and a resorbable membrane. These
results are in agreement with those of
Paknejad et al.33, who reported that graft-
ing a gap with xenograft failed to prevent
bone resorption.
In conclusion, the findings obtained in
this study suggest that the ‘flapless without
graft’ technique shows similar results re-
garding the horizontal change in the buc-
cal alveolar bone when compared to the
‘flap with graft’ technique for immediate
implant placement in a premolar extrac-
tion site with a horizontal gap >2 mm,
when the bone plate is intact. Further
studies with a longer follow-up period
are needed to confirm these findings.
Funding
No funding received.
Competing interests
None.
Please cite this article in press as: Naji BM, et al. Immediate dental implant placement with a horizontal gap more than two millimetres:
a randomized clinical trial, Int J Oral Maxillofac Surg (2020), https://doi.org/10.1016/j.ijom.2020.08.015
Implant placement with horizontal gap 2 mm
Group III
Flapless without graft Between the three groups
0.71  0.49 <0.001*
Ethical approval
This randomized clinical study was per-
formed in accordance with the Declaration
of Helsinki and all procedures were ap-
proved by the Ethics Committee of the
College of Dentistry, Mansoura Universi-
ty (registration number 04060318).
Patient consent
Written informed consent was obtained
from each participant.
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Address:
Ahmed Yaseen Alqutaibi
Prosthodontics Department
College of Dentistry
Taibah University
Alhezam Street
Al Madinah Al Munawwarah
Saudi Arabia
E-mail: Alqutaibiprosthodontist@gmail.com