Adjunctive effect of a polylactide/polyglycolide copolymer in the treatment of deep periodontal intra-osseous defects: a randomized clinical trial.
OBJECTIVE
The aim of this study was to evaluate the clinical outcome of re-constructive surgery in human deep intra-osseous defects with the use of a polylactide/polyglycolide (PLA/PGA) copolymer graft in conjunction with an open flap debridement (OFD) procedure (test group) as compared with OFD procedure alone (control group).


METHODS
Thirty-two patients, each contributing one defect, were selected and completed the 12-month follow-up period. Sixteen patients (eight males, mean age: 49.9 years) received the test treatment, 16 patients (nine males, mean age: 42.8 years) received the control treatment. Clinical recordings, assessed at baseline, 6 and 12 months post-surgery, included defect-specific plaque score, defect-specific bleeding score, probing depth (PD), clinical attachment level (CAL), and recession depth. Surgical procedure aimed to preserve supra-crestal soft tissues at defect site in order to ensure primary closure was used in all cases.


RESULTS
Test and control treatment produced a significant CAL decrease and PD reduction at both 6 and 12 months with respect to baseline value (p<0.000). At 6 months CAL was significantly greater in test compared with control group (p=0.019). Twelve-month CAL gain was 3.6+/-1.5 and 3.4+/-1.4 mm for the test and control group, respectively. At 12 months no significant differences in any of the clinical parameters were observed between groups.


CONCLUSIONS
The results indicate that OFD with and without PLA/PGA graft provide clinically and statistically significant improvements in PD and CAL measurements. However, the additional use of PLA/PGA did not provide an additional benefit in terms of CAL gain and PD reduction compared with OFD procedure.
Minenna
Luigi
L
Research Centre for the Study of Periodontal Diseases, University of Ferrara, Ferrara, Italy.
Herrero
Federico
F
Sanz
Mariano
M
Trombelli
Leonardo
L
D020341:Absorbable Implants; D000328:Adult; D016301:Alveolar Bone Loss / Q000601:surgery*; D001672:Biocompatible Materials / Q000494:pharmacology*; D001861:Bone Regeneration / Q000187:drug effects*; D003774:Dental Plaque Index; D005260:Female; D005889:Gingival Recession / Q000601:surgery; D006801:Humans; D019344:Lactic Acid / Q000494:pharmacology*; D008297:Male; D019647:Oral Surgical Procedures / Q000379:methods*; D017622:Periodontal Attachment Loss / Q000601:surgery; D010512:Periodontal Index; D011100:Polyglycolic Acid / Q000494:pharmacology*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011108:Polymers / Q000494:pharmacology*; D011446:Prospective Studies; D013524:Surgical Flaps
D001672:Biocompatible Materials; D011108:Polymers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid