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Int Poster J Dent Oral Med 9 (2007), No. 1     15. Mar. 2007

Int Poster J Dent Oral Med 2007, Vol 9 No 01, Poster 347

Clinical Comparison Between a Polylactide-polyglicolide Copolymer (Fisiograft®) 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, Romania,
Dr. Darian Rusu, Dr. Adrian Bacila, Periodontal Clinic Dr. Stratul, Timisoara, Romania,
Dr. Anca Benta, Johannes Gutenberg University Mainz, Germany

Date/Event/Venue:
14-15 May 2005
10th Congress of the Balkanic Society of Stomatology BaSS
Belgrade, Republic of Serbia

Introduction

Polylactides and polyglicolides are known from their pharmaceutical (retard medication supports), surgical (resorbable sutures, screws, microplates, membranes, sinus lift procedures etc.) and TE (bioresorbable supports for cultured cells) applications A polylactide-polyglicolide copolymer (PLA-PGL) has been documented clinically to enhance bone regeneration in closed bone defects (Bucci et al.1999, Piatelli et al. 2000, Piatelli 2003, Serino et al. 2003, Rimondini et al.2005) and to sustain periodontal healing in intrabony defects (Stratul et al. 2004). So far, there are no controlled clinical studies to compare the effect of the PLA-PGL with the effect of other "biological agents" in treating deep intrabony defects.

Objectives

Aim of this clinical controlled study was to compare the treatment of deep intrabony defects with the PLA-PGL copolymer Fisiograft® (Ghimas s.p.a., Casalecchio di Reno, Italy) to the enamel-matrix-protein-derivative EMD Emdogain® (Straumann AG, Waldenburg, Switzerland).

Material and Methods

Nineteen patients (11 male and 8 female), between 32-61 years old, with moderate to severe periodontitis, light- or non-smokers, and displaying a total of 26 deep intrabony defects, were treated either with the combination of flap surgery + Fisiograft® (test) or with FS + EMD (control). 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-samples test was used to compare the differences between baseline values and the values measured six months after and the Mann-Whitney U independent-samples test was used for comparison between the groups. The alpha-error was set 0.05, and the power of the study 0.57. Surgery was performed under local anesthesia. A full thickness flap was raised after intrasulcular incision, without using release incisions. 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. Fisiograft® was placed into the defects of the test group. Application form of the product (gel, granules, sponge, gel+granules) was randomly assigned to each defect.The amount of material did not exceed the margins of the defect. The defects of the control group underwent the same surgical protocol, except they were filled with Emdogain® gel. Post surgical care included antibiotherapy for one week (3x500 mg Amoxycilin daily) and 0.2% Chlorhexidin (Dentaton®, Ghimas s.p.a., 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

No adverse healing response was observed. No signs of inflammation, infection, allergy or severe pain were present. Pre- and postoperative mean values of the PD, GR and CAL in the two treated groups are displayed in the table No.1 and table No.2.

Patient Nr. Tooth Type Defect Type(walls) PPD (mm) PPD CAL (mm) CAL gain(mm) GR (mm) GR CEJ BD BC BD CEJ BC
   Pre-operativeAfter 6 monthsDiff.Pre-operativeAfter 6 months Pre-operativeAfter 6 monthsDiff.   
11.2.d18358440111064
21.4.d2103720416101-920128
34.3.m2532642110844
43.3.d2734734000862
53.6.m1743743000853
64.8.m2105510640111183
74.6.m293610641321183
81.4.m1835844011972
91.7.m1743743000862
101.1.m1624862242945
113.4.m1743752011752
124.6.m183510642311147
131.7.d294510641211165
Mean  7,773,384,389,084,774,311,311,380,0810,086,233,85
SD  1,480,771,393,571,093,612,721,262,813,302,201,95
Table 1. Six months clinical results of treatment of intrabony defects with Fisiograft®

Patient Nr. Tooth Type Defect Type(walls) PPD (mm) PPD CAL (mm) CAL gain(mm) GR (mm) GR CEJ BD BC BD CEJ BC
   Pre-operativeAfter 6 monthsDiff.Pre-operativeAfter 6 months Pre-operativeAfter 6 monthsDiff.   
12.6.m17349542201073
22126337611321165
32127439632201165
4142844844000963
5142633651022954
6252844862022945
7221734770044945
8221103710820551046
92728628620001091
101.7.m18719811101293
113.6.m18449631211073
124.3.m29369540221174
132.3.m1633743110853
Mean  7,543,853,698,155,852,310,622,001,389,926,083,85
SD  1,201,281,551,141,281,320,771,411,661,121,711,34
Table 2. Six months clinical results of treatment of intrabony defects with Emdogain®

No differences in any of the investigated parameters were observed at baseline between groups (Table 3). Six months after the treatment, the sites treated with PLA-PGL showed a reduction in probing pocket depth(PPD) from 7.77±1.48mm to 3.38±0.77mm (p=0.001) and a change in clinical attachment level(CAL) from 9.08±3.57mm to 4.77±1.09mm (n.s.). In the group treated with EMD, PPD was reduced from 7.54±1.20mm to 3.85±1.28mm (p=0.001), CAL changed from 8.15±1.14mm to 5.85±1.28mm (p=0.016) (Table 4). No or little hard tissue fill was observed radiographically in the defects treated with PLA-PGL.


Treatment CAL (mm) CEJ-BD (mm) CEJ-BC (mm) INTRA (mm)
EMD (n=13)5,85±1,289,92±1,123,85±1,346,08±1,71
Fisio (n=13)4,77±1,0910,08±3,303,85±1,956,23±2,20
Table 3 Intraoperative measurements for the Fisiograft(R) and Emdogain(R) groups

TreatmentBaseline6 monthsDifferenceSignificance
Probing depth
EMD
Fisio
    
7,54±1,203,85±1,283,69±1,55p=0,001
7,77±1,483,38±0,774,38±1,39p=0,001
    n.s. 
Gingival recession
EMD
Fisio
    
0,62±0,772,00±1,411,38±1,66p=0,002
1,31±2,721,38±1,260,08±2,81p=0,001
    n.s. 
Clinical attachment level
EMD
Fisio
    
8,15±1,145,85±1,282,31±1,32p=0,016
9,08±3,574,77±1,094,31±3,61n.s.
   p=0,029 
Table 4. Clinical parameters at baseline and 6 months for the EMD (n=13) and the fisio surgery groups (n=13)

Fig.1 Case A a) The bone defect exposed Fig.1 Case A b) Fisiograft® in place
Fig.1 Case A c) Rx image before treatment Fig.1 Case A d) Rx image at six months

Fig.2 Case B a) The bone defect exposed Fig.2 Case B b) Emdogain ® in place
Fig.2 Case B c) Rx image before treatment Fig.2 Case B d) Rx image at six months

Conclusions

Both treatments resulted in improvements of PPD and CAL. A statistically significant difference between the groups in favor of Fisiograft® group was observed with respect to CAL gain(p=0.029), no statistically significant PPD reduction difference between groups in favor of Fisiograft® was observed. At six months, both therapies seemed to lead to significant improvements of the investigated clinical parameters.

Abbreviations

PLA-PGL: polylactide-polyglicolide
EMD: enamel-matrix-protein-derivative
PPD: probing pocket depth
CAL: clinical attachment level
GR: gingival recession
TE: tissue engineering
PlI: plaque index
GI: gingival index
BOP: bleeding on probing

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

Correspondence address:
Assist. Prof. Dr. Dr. Stefan-Ioan Stratul
Str.Em.Gojdu, no.5
300176 Timisoara
Romania