AIM: 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). MATERIALS AND 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. CONCLUSION: 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.
RCT Entities:
AIM: 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). MATERIALS AND 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. CONCLUSION: 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.