The adjunctive effect of a resorbable membrane to a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis: A randomized clinical trial.

Abstract

To evaluate the potential adjunctive effect of a resorbable collagen membrane covering a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis. Forty-three patients (43 implants) diagnosed with peri-implantitis associated with intra-bony defects were treated with a surgical reconstructive approach that included a xenogeneic bone substitute material. Additionally, resorbable collagen membranes were placed over the grafting material at sites randomly allocated to the test group; conversely, no membranes were placed in the control group. Clinical outcomes, namely probing pocket depth (PPD), bleeding and suppuration on probing (BoP and SoP), marginal mucosal level (REC) and keratinized mucosa width (KMW), were recorded at baseline and 6 and 12 months after surgery. Radiographic marginal bone levels (MBLs) and patient-reported outcomes (PROs) were assessed at baseline and 12 months. A composite outcome (success) was evaluated at 12 months, which included the absence of BoP/SoP, PPD ≤5 mm and reduction of buccal marginal mucosal level (buccal REC) of ≤1 mm. At 12 months, no implants were lost and treatment success was observed at 36.8% and 45.0% of implants in the test and control groups, respectively (p=.61). Similarly, there were no significant differences between groups in terms of changes of PPD, BoP/SoP, KMW, MBL or buccal REC. Post-surgical complications were observed in the test group only (e.g., soft tissue dehiscence, exposure of particulate bone graft and/or resorbable membrane). Longer surgical times (~10min; p < .05) and higher levels of self-reported pain at 2 weeks (p < .01) were observed in the test group. This study failed to demonstrate the presence of added clinical or radiographic benefits of the use of a resorbable membrane to cover a bone substitute material within the reconstructive surgical therapy of peri-implantitis associated with intra-bony defects.