Peri‐implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation (bleeding/suppuration on probing) in the peri‐implant connective tissue and progressive loss of supporting bone. The peri-implant osseous defects associated with the disease are typically crater-like and resemble angular bone defects at teeth. The goal of reconstructive treatment of peri-implantitis is to restore supporting tissues that were lost during disease progression (defect fill) and to preserve esthetics by preventing soft tissue recession.
The objective of this multinational, multicenter randomized controlled trial is to evaluate the clinical efficacy of the use of a bone substitute material in reconstructive surgical therapy at peri-implantitis-associated osseous defects. Primary outcome is treatment success (absence of bleeding/suppuration on probing, probing pocket depth ≤5 mm & ≤1 mm recession of the mucosal margin). Secondary outcomes include radiographic defect fill and patient-related outcome variables.
Study population, design and treatment procedures
The project will be conducted as a two-armed RCT of 5-year duration at 7 European centers. 140 systemically healthy patients (age: ≥18 years) with at least one dental implant diagnosed with advanced peri-implantitis (probing pocket depth ≥7 mm, bleeding/suppuration on probing & bone loss ≥3 mm) will be enrolled. Surgical procedures will include flap elevation, removal of inflamed tissue and mechanical decontamination of implant surfaces. Following random allocation, osseous defects (≥3 mm deep & ≤4 mm wide) will be filled with a bone substitute material in the test group, while no material will be applied in the control group. Mucosal tissues will be sutured to their previous position. Clinical evaluations are performed at 6, 12, 24, 36, 48 and 60 months and radiographs will be obtained at 1-, 3- and 5-year examinations.