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Int Poster J Dent Oral Med 7 (2005), No. 4     15. Dec. 2005

Int Poster J Dent Oral Med 2005, Vol 7 No 04, Poster 297

Clinical Comparison between an Oily Calcium Hydroxide Suspension (Osteoinductal®) and an Enamel Matrix Protein Derivative (Emdogain®) for the Treatment of Intrabony Periodontal Defects in Humans

Language: English

Authors:
Assist. Prof. Dr. Dr. Stefan-Ioan Stratul
Victor Babes University of Medicine and Pharmacy Timisoara, Romania

Dr. Darian Rusu
Periodontal Clinic Dr. Stratul, Timisoara, Romania

Dr. Anca Benta, Prof. Dr.Britta Willershausen, Prof. Dr. Dr. Anton Sculean
Johannes Gutenberg University Mainz, Germany

Date/Event/Venue:
28 October 2004
Hersbsttagung der Neue Arbeitsgruppe Parodontologie NAgP
Mainz, Germany

Poster Award
NAgP Posterpreis fur das beste eingereichte Poster

Introduction

Biologic agents as EMPs and growth factors became recently of increasing interest in the periodontal regeneration. Results of basic research, animal experiments as clinical studies have suggested the influence of an oily Calcium Hydroxide suspension on bone regeneration in closed defects. Its osteostimulative effect, which can be characterized as biologic, seems to rely on factors as the deposit action of the Calcium Hydroxide (sustaining the bone metabolism in a constant, long-lasting mild alkalic environment), the stimulation of the angiogenetic bone growth and, possibly, the concentration of the growth factors next to the defect wall. OCHS have been also proven to reduce the inflammation in the operated site, thus enhancing the wound healing. Histological and radiological analysis, both in animals and humans, suggest a predictable healing in closed bone defects and a certain amount of regeneration in periodontal defects. Such results have recently led to attempts to use the oily Calcium Hydroxide suspension alone or under various combinations, in treating periodontal defects. So far, there is no clinical controlled study to compare the effect of the oily Calcium Hydroxide suspension with EMD in treating periodontal intrabony defects.

Objectives

Aim of this study is to compare the treatment of deep intrabony defects using an OCHS to the treatment with an enamel matrix protein derivative (EMD).

Material and Methods

Thirty patients (14 male and 16 female), with moderate to severe periodontitis, light- or non-smokers, each displaying one deep intrabony defect, were treated either with an oily Calcium Hydroxide suspension (Osteoinductal®, Osteoinductal GmbH, Muenchen, Germany) or with EMD (Emdogain®, Straumann AG, Waldenburg, Switzerland). All patients underwent initial therapy one month prior to surgery. All patients were instructed and motivated to maintain a good oral hygiene level, verified by a reduction of the PI (Silness and Löe) < 1. Before surgery and six months after, the following clinical parameters were registrated: the periodontal pocket depth (PD), the gingival recession (GR) and the clinical attachment level (CAL). All measurements were performed with a rigid periodontal probe (PCP 12, Hu-Friedy), at six sites per tooth (buccal: mesiobuccal, central, distobuccal; oral: mesiooral, central, distooral). Radiographic examination was performed using the conventional RIO technique. For each patient, the highest measured value was taken into account and the mean PD, GR and CAL were calculated. the Wilcoxon paired test was used to compare the differences between baseline values and the values measured six months after, and the Mann-Whitney U independent test was used for the comparisons between the groups. Surgery was performed under local anesthesia. A full thickness flap was raised after intrasulcular incision, using release incisions where necessary. After removal of the granulation tissue, the exposed roots underwent thorough S/RP, using ultrasonic devices and curettes. No resective surgery was performed, nor any root conditioning. Osteoinductal® was placed into the defects of the first group, in direct contact with the rough, vital bone surface. The defects of the second group were treated with EMD, following root conditioning with EDTA(Prefgel®). Post surgical care included antibiotherapy for one week (3x500 mg Amoxycilin daily) and 0.2% chlorhexidin (Dentaton®, Ghimas, Casalecchio di Reno, Italy) mouth rinses, twice a day, for the following two weeks, as gentle debridement of the operated area every second week, during two months.

Results

The healing phase progressed uneventful. No signs of inflammation, infection, allergy or severe pain were present. The clinical parameters at baseline and at 6 months for the Osteoinductal® and the EMD groups, the configuration of the defects and the CAL gain are displayed in the tables No.1, 2, 3 and in the graph No.1

 

Treatment Baseline 6 months Difference Significance
Probing depth
Osteoinductal ® 8,60 ± 2,06 3,27 ± 1,39 5,33 ± 1,40 p < 0,001
Emdogain ® 8,53 ± 2,17 4,13 ± 1,30 4,40 ± 2,20 p < 0,001
n.s.
Gingival recession
Osteoinductal ® 1,60 ± 1,45 2,60 ± 1,72 1,00 ± 1,00 p = 0,007
Emdogain ® 0,47 ± 0,74 1,73 ± 1,49 1,27 ± 1,58 p = 0,01
n.s.
Clinical attachment level
Osteoinductal ® 10,20 ± 2,08 5,80 ± 2,37 4,40 ± 1,40 p < 0,001
Emdogain ® 9,00 ± 1,96 5,87 ± 1,19 3,13 ± 2,45 p < 0,001
p =0.033
Table 1. Clinical parameters at baseline and 6 months for the EMD (n=15) and the Osteoinductal groups (n=15)

 

Graph 1: Graphical distribution of the CAL in the experimental groups at baseline and six months after

 

Osteoinductal®
(n=15)
Emdogain®
(n=15)
1 wall 6 8
2 walls 6 7
3 walls 3 -
Table 2. The configuration of the defects

 

CAL gain (mm) Osteoinductal®   Emdogain®  
% %
0 - - 1 6,67
1 - - 3 20,00
2 1 6,67 3 20,00
3 3 20,00 2 13,33
4 5 33,33 3 20,00
5 2 13,33 2 13,33
6 3 20,00 - -
7 1 6,67 - -
10 - - 1 6,67
Table 3. The CAL gain in the Osteoinductal® and in the EMD group

 

Case A. a) the bone defect exposed Case A. b) Osteoinductal® in situ
Case A. c) Rx image before treatment Case A. d) Rx image six months after the treatment

 

Case B. a) the bone defect exposed Case B. b) Osteoinductal® in situ
Case B. c) Rx image before treatment Case B. d) Rx image six months after the treatment

 

At six months after the therapy, the sites treated with OCHS showed a reduction in probing pocket depth (PPD) from 8.60 ± 2.06 mm to 3.27 ± 1.39 mm and a change in clinical attachment level (CAL) from 10.20 ± 2.08 mm to 5.80 ± 2.37 mm (p<0.001). in the group treated with emd, the ppd was reduced from 8.53 ± 2.17 mm to 4.13 ± 1.30 mm and the cal changed from 9.00 ± 1.96 mm to 5.87 ± 1.19 mm (p<0.001). relatively more hard tissue fill was observed radiographically in the defects treated with emd. both treatments resulted in significant improvements of ppd and cal. a statistically significant difference between the two groups in favor of the ochs group was observed with respect to the cal gain (p=0.033), whereas no statistically significant ppd reduction difference between the groups was observed.

 

Case C. a) the bone defect exposed Case C. b) Emdogain® in situ
Case C. c) Rx image before treatment Case C. d) Rx image six months after the treatment

 

Case D. a) the bone defect exposed Case D. b) Emdogain® in situ
Case D. c) Rx image before treatment Case D. d) Rx image six months after the treatment

 

Conclusions

  1. at six months after the surgery, both therapies led to significant improvements of the investigated clinical parameters.
  2. the treatment with Osteoinductal® resulted in significantly higher CAL gains than the treatment with EMD.
  3. more clinical controlled and histological studies are needed in the future to evaluate the regenerative potential of the oily Calcium Hydroxide suspension Osteoinductal®, when compared to other regenerative approaches.

Abbreviations

OCHS oily Calcium Hydroxide suspension
EMD enamel matrix derivative
PPD periodontal pocket depth
GR gingival recession
CAL clinical attachment level

 

This Poster was submitted by Assist.Prof.Dr.Dr.Stefan-Ioan Stratul.

Correspondence address:
Assist.Prof.Dr.Dr.Stefan-Ioan Stratul
Victor Babes University of Medicine and Pharmacy
str.Em.Gojdu no.5
300176 Timisoara
Romania