Regeneration of peri‐implant dehiscence defects using a synthetic biomaterial. A randomized controlled clinical trial

Abstract

Objectives: To test whether a guided bone regeneration (GBR) procedure for the treatment of peri‐implant dehiscence defects based on the use of a synthetic bone substitute achieves non‐inferior outcomes when compared to the same procedure using a deproteinized bovine bone mineral (DBBM). Methods: The study was designed as a multicenter randomized clinical trial (RCT). Patients were included if they were expected to present a peri‐implant bone dehiscence ≥ 3 mm after implant placement. Implant position was assured by the use of a guided surgery stent. Grafting materials were a synthetic bone substitute in the test group and a deproteinized bovine bone mineral in the control. A crossed‐link collagen membrane was placed in both groups following the principles of GBR. Re‐entry surgery was performed 6 months after implantation. Primary outcome measure was defect height (DH) resolution between baseline and 6 months, measured with a UNC15 periodontal probe. Additionally, volumetric changes of the augmented area were assessed by means of an intraoral scanner. Results: 17 patients have been enrolled, 6 in the control group and 11 in the test group. 12 out of the 17 dehiscence type defects (70.6%) were completely resolved at the time of re‐entry. In the test group, the percentage of DH resolution was 94.3% (6.0 ± 5.0 mm), while in the control group was 88.2% (3.8 ± 4.3 mm), without statistically significant differences between groups. The depreciated bone volume between initial surgery and re‐entry was 34.9% in the test group and 43.2% in the control group, without significant differences. Conclusions: Within the limitations of this preliminary evaluation, it can be concluded that the analyzed synthetic bone graft is non‐inferior to the reference bone substitute in guided bone regeneration simultaneous to implant placement of peri‐implant bone dehiscences.