Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.

160459

Treatment of Non-Contained Infrabony Defects With Enamel

Matrix Derivative Alone or in Combination With a Biphasic
Calcium Phosphate Bone Graft: a 12-Month Randomized
Controlled Clinical Trial
Meritxell Losada*, Rodrigo González†, Àngels Pujol*, Antonio Santos*, José Nart‡

*Associated Clinical Professor, Department of Periodontology, Universitat

Internacional de Catalunya, Spain.
† rd
3 Year Resident Student, Department of Periodontology, Universitat Internacional de
Catalunya, Spain.
‡
Chairman, Department of Periodontology, Universitat Internacional de Catalunya,
Spain.
Background: The use of Enamel Matrix Derivative (EMD) when dealing with non-contained
defects may be limited, as EMD does not maintain a space itself. It has been proposed the use of
combined therapy, using a bone graft in combination with EMD to avoid the collapse of the flap into the
bony defect during the healing time. Therefore the aim of this study is to evaluate the clinical and
radiological healing response of non-contained infrabony defects following treatment with a combination
of EMD and Biphasic calcium phosphate (BC) or EMD alone.
Methods: Fifty-two patients with at least 1 infrabony defect ≥ 3mm in depth with a probing
pocket depth ≥ 6mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic
parameters were evaluated at baseline, 6 and 12 months after surgery. To standardize the procedure an
acrylic stent and a millimeter radiographic grid were used. The primary outcome was the change in
clinical attachment level (CAL).
Results: Analysis of the data demonstrated a statistically significant difference from baseline
within each group (p<0.05), showing a difference in clinical and radiographic parameters at 6 and 12
months. After one year the EMD/BC group achieved a mean PPD reduction of 3.14±1.95mm (39,6%)
and, 3.30±1.89mm (48,7%) in the EMD group. A mean CAL gain of 2.38±2.17mm (24,9%) in the
EMD/BC group and 2.65±2.18mm (36,2%) in the EMD group was obtained. The reduction in the
infrabony component was 2.71±1.79mm (57,9%) in the test group, and 2.60±2.03mm (28,5%) in the
control group. However, there were no statistically significant differences between treatment groups.
Conclusions: It was concluded that the treatment of non-contained infrabony defects with EMD,
with or without BC, resulted in statistically significant better results after 12 months when compared to
baseline measurements. In contrast, the combined approach did not result in a statistically significant
improvement.

KEY WORDS:
clinical trial, enamel matrix proteins, bone grafting.
Vertical or angular periodontal bone defects are caused when subgingival plaque
continues an apical progression along the root surface.1 If these angular defects are left
untreated, a continuous progression of the lesion will occur.1 Periodontal regeneration
of the lost attachment apparatus will improve the short and long term prognosis of
periodontally affected teeth.2
Periodontal regeneration can be defined histologically as the regeneration of the
tooth supporting tissues, which involves the alveolar bone, cementum and periodontal
ligament, over a previously diseased root surface.3 Since the 1980, non-absorbable and
absorbable membranes in combination with different bone grafts have been used to
achieve this goal.4

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

When attempting to perform this procedure, the defect morphology, such as number
of remaining walls, depth and width, play a significant role in the outcome of
regeneration. It has been found a positive correlation between the number of remaining
walls and the regenerative potential.5 Furthermore, defects with a depth ≥4mm and a
radiographic angle ≤25° have the greatest potential to regenerate.4-6
In the late 90s, enamel matrix derivative (EMD)§ was introduced as a biologic
approach to periodontal regeneration.7 EMD is a purified acidic extract of developing
embryonal enamel derived from 6 months old piglets. It is mainly composed of
amelogenins, a family of hydrophobic proteins, which accounts for 90% of the organic
constituent of EMD.7 EMD mode of action is by stimulating the cells from the
Hertwig´s epithelial root sheath (HERS).7, 8 EMD adsorbs to denuded dental surface and
to both collagen and hydroxyapatite.8 It is suggested that EMD stimulates mesenchymal
cell growth and causes a cytostatic effect on the epithelial cells.9 EMD will remain on
the treated site for at least 4 weeks, allowing enough time for the periodontal ligament
cells to recolonize the lesion.8-10 Furthermore, EMD has a plaque inhibitory effect, not
allowing the growth of gram-negative bacteria but allowing gram-positive bacteria to
colonize.11
Some studies have compared the use of EMD versus guided tissue regeneration not
finding any statistical differences between both regenerative procedures.12, 13 However,
Sanz et al.14 in 2004 achieved better results when applying EMD instead of guided
tissue regeneration. They concluded that this tendency was due to the higher rate of
complications when performing guided tissue regeneration than when applying EMD.14
Siciliano et al.15 in 2011 compared the use of EMD versus guided tissue regeneration by
means of a non-resorbable titanium reinforced membrane in non-contained defects.
They concluded that in this type of defect morphology, the application of EMD alone
appeared to yield less PD reduction and CAL gain com- pared to guided tissue
regeneration therapy.15
When dealing with non-contained defects, missing supportive bony walls, EMD
does not maintain a space itself.16 It has been then suggested a combined approach of
EMD and a bone graft to enhance a better outcome than EMD applied alone.16, 17 The
use of a bone graft may hinder the collapse of the flap into the bony defect during the
early phases of healing.16 Some reports have found better results on PPD reduction,
CAL gain and bone fill when applying EMD and a bone graft 17-19
A biphasic calcium phosphate (BC)|| consisting of 60% hydroxyapatite (HA) and
40% ß-tri-calcium phosphate (TCP) in a particulate form that has been recently
introduced as a grafting material for the treatment of various types of periodontal, peri-
mplant and bone defects.20 An animal model study concluded that the use of this
HA/TCP ratio (60%/40%) showed accelerated new bone formation and greater
attachment level gain.21
Following the combined regenerative approach, the aim of this study is to evaluate
clinical and radiologically the healing response of non-contained infrabony defects
following treatment with a combination of EMD and BC or EMD alone.

MATERIAL AND METHODS:

This is a prospective randomized double blind clinical controlled trial (RCT). Fifty-two
systemically healthy adult patients (19 females and 33 males) ranging in age from 35 to
70 years, with moderate to severe chronic periodontitis with at least 1 infrabony defect
being >3mm in depth were included. Patients were recruited and treated since

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

September 2011 until March 2015 at the Department of Periodontology dental clinic
from the Universitat Internacional de Catalunya, Barcelona, Spain. The sample size
calculation was based on a previous pilot study in 10 patients in which differences in
between groups where set at 1mm in CAL gain as the primary outcome, with an alpha
error of 0.05, a beta error of 0.9 and with a SD of 1.2mm. Thus, the sample size was
established for 52 patients including dropouts. The Ethics Committee at the Universitat
Internacional de Catalunya approved the study design with the code PER-ECL-2011-
04-CM. This RCT is registered (ID: NCT02828423) and follows the CONSORT
guidelines as well as the Helsinki declaration for human research. Prior to the initiation
of this study, an informed consent was obtained from each patient after explaining the
nature of the investigation. The inclusion criteria for patients and sites were: 1) patients
in treatment for periodontal disease without systemic diseases or conditions that could
influence the therapy outcome, 2) not taking any medication that would affect
periodontal healing, 3) high standards of oral hygiene (O’Leary et al.22 PCR <20%), 4)
compliance with the maintenance program, 5) presence of at least 1 infrabony defect
with a probing depth ≥6mm after reevaluation of the hygienic phase and an infrabony
component of ≥3mm as detected on radiographs, with any angulation, and exhibiting a 1
or 2 wall infrabony defect, 6) presence of at least 2mm of keratinized tissue on the
buccal aspect of the selected tooth, and 7) teeth have to be vital or properly treated
endodontically. The exclusion criteria included 1) patients with any debilitating
systemic disease or medication that could affect the periodontium 2) heavy smokers
(>10 cigarettes/day) 3) teeth with class II or III furcation involvement 4) mobility >
class 2 and 5) strict or predominantly 3-wall defects

Treatment Procedures
Initial periodontal therapy included supragingival scaling with oral hygiene instructions
until the patient achieved high standards of oral hygiene (PCR < 20%), subginigval
scaling and root planing under local anesthesia and occlusal adjustment when indicated.
Four weeks after the completion of phase I therapy, a re-evaluation was performed to
confirm the inclusion of the patients in this clinical research. Probing pocket depth,
attachment level, mobility, bleeding on probing and plaque index were assessed. Teeth
with mobility greater than class I (Miller23 1950) were splinted to adjacent teeth with a
twisted wire and light-cured resin.
Before proceeding with the surgical treatment, cast models were obtained from an
alginate impression to fabricate an acrylic resin occlusal to standardize clinical
measurement with the periodontal probe¶. The occlusal stent was fabricated using the
technique described by Lekovic et al. 2000 (Figure 1).24
Two weeks after re-evaluation, patients were scheduled for surgical therapy.
Photographs and standardized reproducible intraoral digital radiographs were obtained
from each operated site. The film holder# was modified by placing a registration
material** on the bite blocks to index the dentition. A paralleling cone technique††
(7mA-60kV/20ms) was used. A radiopaque millimeter grid was positioned over the
radiograph‡‡ to assess the radiographic measurements. Both the occlusal stent and the
radiographic bite blocks with the millimeter grid provided a well-defined and
reproducible measurement at each defect and at each examination time point. (Figure
1).

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

Clinical and Radiographic Parameters

Clinical measurements. Two experienced examiners (AP, JN), who were not
involved in the surgical procedure, assessed the clinical examinations. A calibration
exercise was performed to obtain intra- and inter-examiner reproducibility. According
to Polson et al.25 a training program was followed until reproducibility of 90% was
achieved.
The following clinical measurements were taken at the same day of the surgery
(baseline) at 6 and 12 months follow-up: 1) Plaque Control Record22 (PCR); 2) Gingival
index26 (GI); 3) Bleeding on probing (BOP); 4) Probing pocket depth (PPD); 5)
Gingival recession (GR); 6) Clinical attachment level (CAL) and 7) Mobility23 (M).
PPD, GR and CAL were recorded at the deepest site per tooth: using the same
periodontal probe and a customized stent with guiding grooves.

Radiographic measurements. The infrabony component was recorded in

millimeters. The following measurements27, 28 were made: 1) distance from the
cemento-enamel junction to the bottom of the defect (CEJ-BD), 2) distance from the
CEJ to the most coronal extension of the alveolar bone crest (CEJ-BC). The infrabony
component (INFRA) of the defects was defined as (CEJ-BD) – (CEJ-BC), 3) angulation
of the defect, assessed by measuring the angle between the intersection of a line across
the long axis of the tooth and the delimitation of the wall of the defect (GeoGebra®
5.022.0-3D), and 4) number of the remaining walls of the defect, recorded by visual
analysis of the radiograph, and confirmed intrasurgically.

Surgical Procedures
Randomization was performed prior to surgical therapy by a computed-generated table.
To conceal allocation, opaque envelopes were opened the day of the surgery. One
experienced periodontist (AS) performed all surgical procedures assisted by 2nd and 3rd
year periodontal residents (RG, ML). Two different approaches for the treatment of
infrabony defects were compared in a randomized controlled double blind clinical trial.
Neither the examiners nor the patients were aware of the type of procedure performed.
Both surgical procedures were performed under local anesthesia and the same surgical
access to the bony defect was performed. An envelope full thickness mucoperiosteal
flap was raised buccal and lingually following simplified papilla preservation
incisions.29 All granulation tissue was removed from the defects and the roots were
thoroughly scaled and planed using hand and ultrasonic instruments. The test group was
treated by filling the infrabony defect with EMD/BC and the control group with EMD
alone. Previously, root surfaces adjacent to all defects were treated with 24% EDTA
gel§§ for 2 minutes according to manufacture’s instructions. The root was subsequently
rinsed with saline and the bleeding was controlled with the use of gauzes. Topical
application of EMD on the root surface in an apical-coronal direction was performed in
both study groups. In the test group, the defect was filled in addition with a mixture of
the remaining EMD in the syringe and BC. For both treatments, the mucoperiosteal flap
was re-positioned and sutured with a non-absorbable monofilament 6/0 suture|||| with a
horizontal mattress suture and simple suture technique. (Figure 2)

Postoperative Care
All patients were instructed to rinse twice daily for 2 weeks with 0,12% clorhexidine
gluconate. Tooth brushing and interproximal toothbrush on the regenerated area were

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

initiated at the 15th day after surgical treatment. An analgesic and anti-inflammatory
medication (ibuprofen 600mg 1/8hours) were provided for postoperative pain control
for 3 days. Antibiotic (Amoxicillin 750mg 1/8hours or Clindamycin 300mg 1/6hours)
was provided as well during 7 days. The sutures were removed after 2 weeks, and the
surgical sites were gently cleansed with sterile saline using a cotton swab. The patients
were scheduled for recall visits on the 1st and 2nd week after surgical treatment and then
at 1, 3, 6, and 12 months postoperatively. Oral hygiene was evaluated and supragingival
prophylaxis was carried out at each recall visit. Neither probing nor subgingival
instrumentation were performed during the first 6 months after surgery.

Statistical Analysis
The primary outcome variable was the change in CAL recorded in millimeters at 6 and
12 months after surgery. Secondary variables included PPD reduction, GR change and
infrabony defect reduction (INFRA). The statistical analysis was performed using the
software SPSS version 21. The data did not show a normal distribution after testing for
the normality using a Shapiro-Wilk test; in consequence non-parametric tests were used.
Equality of variances was identified by using the Levene test. Intra and inter- group
comparisons were performed to evaluate changes from baseline to 6 and 12 months by
using U-Mann Whitney test for quantitative variables and χ2 test for binary variables.
The p value was set at 0.05 (with a 95% of confidence). As an additional analysis,
logistic regression analysis was performed to predict the CAL gain at 12 months on the
basis of angulation and number of residual bonny walls of the defect. The calibration
test was performed intra- and inter-examiners by using a Kappa index to establish the
power of concordance in the measurements performed by the two clinicians.

RESULTS:
Study Population
A total of fifty-two participants were included in the study (26 in the control group and
26 in the test group). Six patients denied participating in the postoperative visits before
the first 6-month evaluation (1 patient in the control group and 5 patients in the test
group), resulting in 46 individuals completing the study. In addition, two more patients
(both from the control group) did not continue with the investigation before the 12-
month evaluation. However, they were included for the 6-month analysis.
Forty-six non-contained infrabony defects from forty-six patients were analyzed.
The infrabony defects were predominantly composed by 1-wall, 2-wall or combination.
The mean infrabony depth was 5.24±1.92mm in the control group and 4.66±1.19mm in
the test group. The demographic patterns of the population and the location and
distribution of the infrabony defects are described in Table 1.
No complications during the healing period were reported except for those inherent
to surgery like mild swelling or pain. No adverse reactions were reported to none of the
regenerative materials employed.

Clinical and Radiographic Outcomes

The initial analysis of the data showed a homogeneous distribution between
experimental groups.

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

During all the observational period, plaque index was maintained under the 25% in
both experimental groups. However, the deterioration in PCR, GI and BOP from
baseline to the 12-month evaluation was statistically significant in both groups.
At baseline PPD, GR, CAL and INFRA showed no statistically significant
differences between experimental groups, exhibiting homogeneity among them. After
treatment, both groups experimented clinical and radiographic changes in all parameters
that were statistically significant at 6 and 12 months from baseline (Table 2).
Differences between baseline and 6 months and baseline and 12 months are shown in
Table 3. In the EMD group, the PPD reduction was 3.72±1.78mm (47,4%), the CAL
gain was 3.0±1.84mm (33,5%) and the INFRA reduction was 2.44±2.23mm (46,2%) at
6 months. In the EMD/BC group, the PPD reduction was 3.23±1.97mm (40,7%), the
CAL gain was 2.28±2.07mm (23,9%) and the INFRA reduction was 2.33±1.95mm
(50%) at 6 months. Conversely, differences between treatment groups were not
statistically significant in any time-point and for any parameter. Tables 2 and 3 show the
intra- and inter-group comparisons.
Considering the distribution of CAL gain frequency, half of the infrabony defects
obtained ≥ 3mm of CAL gain (57.9% in the EMD group and 47.8% in the EMD/BC
group). When the CAL gain threshold was set at 2mm more than the 60% of the
infrabony defects achieved at least 2mm of CAL gain (66.6% in the EMD group and
62.1% in the EMD/BC group).
In a secondary analysis, it was intended to find the influence of the angle and the
number of residual bony walls to the final attachment gain. The CAL gain was set at
3mm. The regression analysis showed that the probability of gaining ≥3mm of
attachment was diminished as the angulation score increased. In addition, the angulation
parameter was divided in three categories: wide, narrow and intermediate angles
according to the inter-quartile range resulting in angulation <24.75º and angulation
>36.06º. The probability of gaining ≥3mm of attachment was 2.57 times higher if the
treatment was performed in an angle <24.75º than in wider angles. (Table 4)
The same analysis was done with the number of residual walls parameter. In that
case, the probability of gaining ≥3mm of attachment was reduced in 0.55 times when
the defect was composed by only 1 wall compared to 2-wall defect. (Table 4)

DISCUSSION:
The results of the present study demonstrated favorable outcomes with either EMD or
the combination therapy of EMD and BC after 12 months. Both therapies resulted in
statistically significant PDD reduction, CAL gain and bone fill of non-contained
infrabony defects. However, no differences were found between test and control groups.
The results of the control group are in agreement with several controlled clinical
trials.15, 28, 30-33 Heijl et al.30 demonstrated that the treatment of non-contained
periodontal defects with EMD resulted in increased PPD reduction and CAL gain when
compared to OFD. On the other hand, as previously mentioned, Siciliano et al.15
coincide with the results of the control group of the present investigation but revealed
that the GTR group showed statistically significant superior results than EMD alone in
1-2 walls defects.
When EMD was combined with BC, it resulted in significant improvement of
clinical and radiographic parameters compared to baseline. A prospective case series34
evaluated clinical and histologically the regeneration of infrabony defects with the

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

combination therapy of EMD and BC. The results agree with the present investigation.
Moreover, they found that the healing was by means of long junctional epithelium, graft
particles encapsulation and absence or minimum bone formation, which is in agreement
with a recent systematic review in combination therapy with EMD and alloplastic
grafts.35
In the last years, many clinical trials have been published regarding the combination
therapy with EMD and BC.28, 31-34, 36 The majority of these investigations28, 31, 32, 36 are in
agreement with the present results. Hoffman et al.31 reported statistically significant
results that were maintained after 36 months with no differences between treatment
modalities. Pietruska et al.36 found similar results after 4 years of follow-up.
Interestingly, only one clinical trial by De Leonardis et al.33 differed from the previous
results mentioned. After 24 months, the authors reported statistically significant
differences favoring the combination therapy of EMD/BC compared to EMD alone.
These results differ from the majority of the published studies and from the present
investigation. 28, 31, 32, 36 The main difference in methodology was that De Leonardis did
not follow any standardized system to obtain the clinical and radiographic
measurements, compared to the present study and the majority of the publications.
The re-evaluation at 4 weeks after non-surgical therapy is still controversial because
the response continues at least up to 6-9 months later, and this may result not just in
clinical improvements but also in radiographic bone fill.37 Moreover, smoking and
plaque control through oral hygiene and maintenance are major factors influencing the
regenerative therapy outcome.2 In the present study, only a small portion of participants
were smokers. During all the research period, the patients maintained an acceptable
plaque index under 25%. However, the differences between baseline and 12 months
were statistically significant, showing deterioration in the patients’ oral hygiene. This
may have influenced the final results, as smoking and poor plaque control may
negatively affect the prognosis.2 In addition, BC has been described as an
osteoconductive material.21 However, not all the published investigations are in
agreement.38 It has been evidenced that BC is not a good osteoconductor and has a very
low reabsorption rate.38 Furthermore, only a very low proportion of graft particles are
completely surrounded by new bone after regeneration therapy and are directly involved
in bone formation.38 The results of this investigation point an inhibitory effect of the
regeneration due to the reabsorption process of BC, the graft surface and the
morphology of the graft particles. They suggest that when the reabsorption process is
initiated alkaline phosphatase is released, increasing the ph, which does not favor the
regeneration. In addition, they mentioned that the irregularity of the graft particles
reduce the surface area not favoring a proper adaptation to the defect and the
neovascularization. Thus may explain the lack of clinical and radiographic significant
differences with the combination therapy to EMD alone.
A regression analysis was performed to show the effect of defect angulation and the
number of remaining bony walls on the attachment outcomes after the regeneration
procedure. The present investigation concluded that the probability of gaining ≥3mm of
attachment was higher if the treatment was performed in a narrow angle and in a 2-wall
infrabony defect rather than a wider angle or a 1-wall defect. This association is in
agreement with several studies that concluded that a non-contained morphology of the
defect was related to less CAL gain.5, 39-42 A study where 242 infrabony defects were
treated with GTR 40, showed that defects with a radiographic angle of ≤25º gained more
attachment than defects with an angle of ≥37º after one year of treatment. Another study
analyzing the defect angle in regenerative therapy with EMD43 reached the same results.

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

Narrower defects ≤22º were associated with an increased probability of CAL gain
>3mm compared to wider angles (≥36º). The results of the present investigation match
with those reported by Tsitoura43 and Cortellini.40 In contrast, we did not find
statistically significant differences in between groups. This might be explained by the
differences in the defect morphology in the sample size configuration. The present study
only accepted 1 or 2 wall infrabony defects. However, in the above mentioned
investigations the percentage of 2 and 3 wall defects reached the 70% of the sample size
while 1 wall defect configuration were less than 30%. This may have impacted the final
results.

CONCLUSION:
In conclusion, both approaches resulted in statistically significant better results after 12
months compared to baseline measurements in the treatment of non-contained infrabony
defects. The combination approach did not result in a statistically significant PDD
reduction, CAL gain and bone fill when compared to EMD alone.

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Correspondence author: Àngels Pujol Garcia, Josep Trueta s/n 08195 Sant Cugat del
Vallès, Barcelona Spain (apujol@uic.es)
Submitted July 12, 2016; accepted for publication November 21, 2016.

Figure 1 -
A) Acrylic occlusal stent. B) Bite block and millimeter grid.

Figure 2 –
Surgical procedure EMD/BC approach. A) Preoperative radiograph. B) Baseline situation. C) Incisions
performed by a simplified papilla preservation technique. D) 1-wall infrabony defect after debridement.
E) Root conditioning with EDTA 24%. F) An horizontal mattress suture was left prepared. G) EMD
application. H) BC application. I) Infrabony defect filled with EMD/BC. J) Suture. K) Twelve months
follow-up radiograph.
Table 1 –
Population and infrabony defect distribution.
Variable Control (EMD) Test (EMD/BC)
Demographic data
Patients (n) 25 21
Age (years±SD) 50.20±9.48 54.90±10.77
Gender M/F (n) 14/11 15/6
Smoker yes/no (n) 3/22 4/17

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Infrabony Defect
Location
Maxilla 11 7
Mandible 14 14
Anterior teeth 8 8
Premolars 10 8
Molars 7 5
Morphology (n/%)
1 wall 5 (20%) 5 (29.4%)
2 walls 15 (60%) 12 (70.6%)
1-2 walls 5 (20%) 0
X-ray measurements
Depth (mm±SD) 5.24 ± 1.92 4.66 ± 1.19
Angulation (°±SD) 30.20 ± 7.34 32.55 ± 8.46
Table 2 –
Clinical and radiographic outcomes (mm) at 6 and 12 months.
Variable/Group Baseline 6 Months P value 12 Months P value P value
(Baseline- (Baseline- (6Months-
6Months) 12Months) 12Months)
PPD
Control (EMD) 7.88 ± 1.61 4.16 ± p<0.05 4.04 ± p<0.05 NS
1.43 1.88
Test (EMD/BC) 7.95 ± 1.71 4.71 ± p<0.05 4.8 ± 1.63 p<0.05 NS
1.61
Difference NS NS NS
GR
Control (EMD) 1.2 ± 1.35 1.76 ± p<0.05 1.68 ± p<0.05 NS
1.78 1.34
Test (EMD/BC) 1.61 ± 1.46 2.66 ±1.59 p<0.05 2.47 ± 1.6 p<0.05 NS
Difference NS NS NS
CAL
Control (EMD) 8.96 ± 1.95 5.96 ±2.09 p<0.05 5.72 ± p<0.05 NS
2.49
Test (EMD/BC) 9.57 ± 2.54 7.28 ±2.1 p<0.05 7.19 ± p<0.05 NS
2.33
Difference NS NS NS
INFRA
Control (EMD) 5.2 ± 1.92 2.8 ±1.93 p<0.05 3.72 ± p<0.05 NS
1.76
Test (EMD/BC) 4.66 ± 1.19 2.33 ± p<0.05 1.96 ± p<0.05 NS
1.93 1.59
Difference NS NS NS
NS = not significant

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Journal of Periodontology; Copyright 2016 DOI: 10.1902/jop.2016.160459

Table 3 –
Variable Changes (mm) between baseline and 6 months and baseline and 12 months.
Group Baseline to 6 Months Baseline to 12 months
PPD reduction
Control (EMD) 3.72 ± 1.78 3.30 ± 1.89
Test (EMD/BC) 3.23 ± 1.97 3.14 ± 1.95
Difference NS NS
GR change
Control (EMD) -0.56 ± 1.22 -0.65 ± 13
Test (EMD/BC) -1.04 ± 1.46 -0.85 ± 1.45
Difference NS NS
CAL gain
Control (EMD) 3.0 ± 1.84 2.65 ± 2.18
Test (EMD/BC) 2.28 ± 2.07 2.38 ± 2.17
Difference NS NS
INFRA reduction
Control (EMD) 2.44 ± 2.23 2.60 ± 2.03
Test (EMD/BC) 2.33 ± 1.95 2.71 ± 1.79
Difference NS NS
NS = not significant
Table 4 –
Logistic regression analysis of the factors that affect the probability of obtaining CAL gain ≥3mm.
Parameter Odds ratio 95% Confidence interval p value
Radiographic defect angle (narrow versus wide) 2.57 0.361-18.326 0.346
Number of walls (1-wall versus 2-walls) 0.55 0.159-1.920 0.351
§
EMD: enamel matrix derivative (Emgogain®)
Emdogain, Straumann Institute, Basel, Switzerland.
||
BC: Biphasic Calcium Phosphate (Bone Ceramic®)
Straumann BoneCeramic, Straumann Institute.
¶
Hu-Friedy CP-8.
#
XCP® Film Holders, DENTSPLY, Australia.
** Optosil® Confort Putty, Heraeus.
††
DÜRR DENTAL®, VistaScan Mini Plus.
‡‡
Kodak CR®, nº2.
§§
PrefGel®, Straumann Institute, Basel, Switzerland.
||||
Polypropylene Aragó®, Barcelona, Spain.

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