Comparative evaluation of fisiograft (polylactic and polyglycolic acid co-polymer) with open flap debridement (OFD) versus open flap debridement (OFD) alone in the treatment of periodontal intra-bony defects: A clinical and radiographic study

Abstract

Background: Among treatment modalities, grafting of biomaterials/bone substitutes has been used with varying success to accomplish the reconstruction of the lost periodontal attachment apparatus. Biodegradable polymers, especially those belonging to the family of polylactic acid (PLA) and polyglycolic acid (PGA), are playing an increasingly important role in bone reconstructive procedures. The aim of this study was to evaluate the clinical outcome of reconstructive surgery in human deep intrabony defects with the use of fisiograft (polylactic and PGA copolymer) with open flap debridement (OFD) versus OFD alone in the treatment of periodontal intrabony defects. Materials and Methods: Thirty 2- or 3-walled intrabony defects were treated in 15 (ten male and five female) patients with a mean age of 50.4 years. All had completed nonsurgical treatment and a period of supportive periodontal therapy. The study used a split-mouth design where two intrabony defects were randomly chosen to receive fisiograft (polylactic and PGA copolymer) with OFD (Group 1) on 15 sites and remaining 15 sites were chosen only for OFD alone (Group 2). Statistical Analysis: Wilcoxon's signed-rank test as an alternative to paired t-test and Mann–Whitney U-test as an alternative to unpaired t-test were used for statistical analysis. Results: There was a decrease in probing pocket depth of 3.93 ± 0.08 mm for PGA/PLA with OFD and 3.14 ± 0.41 mm for OFD alone with a mean gain of relative clinical attachment level of 3.81 ± 0.30 and 2.46 ± 0.03 for PGA/PLA with OFD and OFD alone, respectively. Gingival margin position was 0.667 ± 0.51 mm and 3.626 mm for the PGA/PLA with OFD and OFD alone. The mean amount of defect fill for PGA/PLA with OFD and OFD alone was 1.80 ± 0.86 mm and 1.20 ± 0.94 mm, with a mean change in the level of alveolar crest after 6 months being 0.267 ± 0.46 and − 0.86 ± 0.74 for the two groups, respectively. The mean difference in percentage of original defect resolved when compared between the test and control groups 6 months postoperatively was found to be 31.85% which was statistically significant (P = 0.001). Conclusion: In the present study, fisiograft (polylactic and PGA copolymer) with OFD group showed better results than where OFD alone was used in the treatment of periodontal intrabony defects in terms of both clinical as well as radiographic assessment. Although Fisiograft® has shown promising results on clinical and radiological evaluation in the present study, it would be inappropriate to draw definite conclusions regarding the nature of the defect fill.

Keywords

• Open flap debridement
• periodontal intrabony defects
• polylactic and polyglycolic acid copolymer