Bone Substitute Material in the Surgical Therapy of Peri-Implantitis-3-Year Outcomes of a Randomized Controlled Trial.

Objective: To evaluate the potential mid-term benefit of the use of a bone substitute material in the reconstructive surgical treatment of peri-implantitis.

Methods: A total of 120 subjects (127 implants) affected by peri-implantitis were followed over 3 years in a multicenter randomized clinical trial. Participants had been randomized to either control (access flap surgery) or test group (access flap surgery and bone substitute material). Clinical, radiographic, and patient-reported outcomes were assessed. The primary outcome was a composite measure including probing pocket depth ≤ 5 mm, absence of bleeding and suppuration on probing, soft tissue recession ≤ 1 mm, and implant neither reoperated nor lost. In an additional outcome (disease resolution), we allowed for one bleeding site and did not consider recession.

Results: While 14 implants (11%) were lost and a second surgical intervention had been performed at 3 implants (2.4%), pronounced improvements of clinical parameters were noted at remaining implants in both treatment groups at the 3-year follow-up. This was illustrated by a 3.2-3.5 mm reduction in probing pocket depth and a marginal bone level gain of 1.1-1.3 mm. The primary composite outcome, however, was only achieved at 14% of implants. The second composite outcome defining disease resolution was accomplished at 39% of implants. Patient-reported outcomes were generally favorable.

Conclusion: At 3 years, the use of a bone substitute material in the surgical therapy of peri-implantitis did not result in a clear benefit over access flap surgery alone.

Trial registration: ClinicalTrials.gov identifier: NCT0307706.