Comparison of a bioabsorbable GTR barrier to a non-absorbable barrier in treating human class II furcation defects. A multi-center parallel design randomized single-blind trial.

This multi-center single-blind study compared clinical outcomes following guided tissue regeneration (GTR) treating human Class II furcation defects with a new polylactic-acid-based bioabsorbable barrier (test treatment) or a non-absorbable ePTFE barrier (control treatment). Clinical parameters evaluated were change in vertical attachment level (VAL), horizontal attachment level (HAL), probing depth (PD), and gingival margin location (REC). Surgical treatment resulted in clinically and statistically equivalent changes when comparisons were made between test and control treatments. VAL gain was 2.0 mm for test and 1.6 mm for control groups; HAL gain was 2.1 mm for both test and control groups. PD reduction was 2.3 mm for the test group and 2.1 mm for the control group. Test sites experienced an additional 0.3 mm of recession beyond baseline; control sites, 0.5 mm. Within-group comparisons showed that the amount of recession was not significantly different from baseline in the test group. Recession in the control group was significantly different from baseline. All other parameters in both the test and control groups were significantly different from baseline. Evaluation of safety data indicated no significant differences between test and control treatments, although there was a strong trend for the control group to have more postoperative abscess or suppuration than test sites (control = 11; test = 4; P = 0.06).

RCT Entities:   Population Interventions Outcomes