Background: The aims of the present multi-center, randomized, controlled clinical trial were: 1) to compare the efficacy of the simplified papilla preservation flap with and without a barrier membrane in deep intrabony defects; 2) to evaluate the postoperative morbidity and surgical complications; and 3) to preliminarily test the impact of baseline tooth mobility on clinical outcomes.
Methods: This parallel group, randomized, multi-center, controlled clinical trial involved 112 patients in 8 periodontal practices in 4 countries. A deep intrabony defect in each patient was accessed with the simplified papilla preservation flap. In the test defects, a bioabsorbable membrane was positioned. Patients' experiences with the surgical procedure and postoperative period were evaluated with a questionnaire. Clinical outcomes included clinical attachment level (CAL) and probing depth (PD) changes.
Results: Complete observations were available for 55 test and 54 control defects. CAL gains at 1 year were 3.5 +/- 2.1 mm in the guided tissue regeneration (GTR) group and 2.6 +/- 1.8 mm in the control group (P = 0.0117). CAL gains > or = 4 mm were observed in 50.9% of GTR sites and 33.3% of control sites. A significant center effect of 2.1 mm was observed (P= 0.01). Initial PD (P= 0.01) and baseline tooth mobility (P= 0.036) were significant covariates. During the procedure, 30.4% of test and 28.6% of controls reported feeling moderate pain, and subjects estimated the hardship of the procedure at 24 +/- 25 visual analog scale (VAS) units in the test group, and at 22 +/- 23 VAS in controls. In terms of the investigated outcomes, differences between test and control groups were not statistically significant. Among the postoperative complications, edema was most prevalent at week 1, and more frequently associated with the test treatment (P= 0.01). In the test group, 53.6% of membranes were exposed at week 3.
Conclusions: The present study further supports the added benefits of guided tissue regeneration with respect to access flap alone in the treatment of deep intrabony defects, as well as the general efficacy of GTR in different clinical settings. Furthermore, our study indicates a possible influence of baseline tooth mobility on clinical outcomes.