Guided bone regeneration at dehiscence comparing synthetic bone substitute versus bovine bone mineral: A multicenter, noninferiority, randomized trial.

Abstract

Aim: To evaluate the efficacy of guided bone regeneration (GBR) for the treatment of peri-implant dehiscence defects using a synthetic bone substitute (SBS) or a deproteinized bovine bone mineral (DBBM) as a bone substitute.

Methods: Patients with expected dehiscence defects following implant placement were randomized to use either SBS or DBBM together with a bioabsorbable collagen membrane over dehiscenced implant surfaces aimed for GBR. The changes in the bone defect size were measured before the GBR procedure and 6 months after implant placement at the re-entry surgery. Secondary outcomes included peri-implant health outcomes, implant cumulative survival rates, bone level changes, and patient-reported outcomes (PROMs) at prosthesis delivery and 1-year follow-up.

Results: Of the 49 included patients, 24 were treated with SBS and 25 with DBBM. In the SBS group, the defect height (DH) at implant insertion was 5.1 ± 2.6 mm and was reduced at re-entry to 1.3 ± 2.0 mm (74.5%). In the DBBM group, the respective changes in DH were 4.1 ± 1.7 mm and 1.5 ± 1.9 mm (63.4%). These differences were not statistically significant (p = 0.216). The complete defect resolution rate was also comparable in both groups without statistical difference (62.5% of patients (15/24) vs. 44% of patients (11/25)). Overall, the marginal bone levels remained stable during the 1-year follow-up in both groups.

Conclusion: The SBS is noninferior to DBBM for simultaneous GBR to implant placement at implant sites with buccal dehiscences in terms of defect resolution and evaluated secondary outcomes (KCT0008393 - this clinical trial was not registered before participant recruitment and randomization).