Treatment of class II furcation involvements in humans with bioresorbable and nonresorbable guided tissue regeneration barriers. A randomized multi-center study.

In this multi-center study 38 patients with contralateral molar Class II furcation defects were treated with GTR therapy using a bioresorbable matrix barrier (test) and a nonresorbable expanded polytetrafluoroethylene (ePTFE) barrier (control). Following flap elevation, scaling, root planing, and removal of granulation tissue, each device was adjusted to cover the furcation defect. The flaps were repositioned and sutured to complete coverage of the barriers. A second surgical procedure was performed at control sites after 4 to 6 weeks to remove the nonresorbable barrier. Before treatment and 12 months postsurgery all patients were examined and probing depths, clinical attachment levels, and position of the gingival margin were recorded. The primary response variable was the change in clinical attachment level in a horizontal direction (CAL-H change). Both treatment procedures reduced the probing depths (P < or = 0.001). Statistically significant gain of clinical attachment level in both horizontal and vertical direction was found at the test sites. At control sites gain of attachment in horizontal direction was statistically significant. The gain of CAL-H was 2.2 mm at test sites compared to 1.4 mm at control sites (P < or = 0.05). At test sites, the gingival margin was maintained close to the pre-surgical level (0.3 mm), whereas at control sites gingival recession was evident (0.9 mm), the difference being statistically significant (P < or = 0.01). Postsurgical complications, such as swelling and pain were more frequent following the control treatment (P < or = 0.05).

RCT Entities:   Population Interventions Outcomes