Surgical treatment of peri‐implantitis lesions with or without the use of a bone substitute—a randomized clinical trial

Aim To assess whether the treatment outcome differed between surgical debridement, with or without a bone substitute. Materials and Methods Forty‐one adults with three‐ or four‐wall peri‐implant bone defects were enrolled in a 1‐year RCT . Surgical debridement (control group), or in combination with a bone substitute (Endobon®) (test group) was performed. Results Radiographic evidence of defect fill (primary outcome) was only significant in the test group ( P  = 0.004). At year 1, no bleeding on probing ( BOP ) in the control and test groups were 7/20 (35%) and 10/21 (47.6%), respectively ( χ 2  = 0.67, P  = 0.41). Plaque scores did not differ by study group at baseline ( P  = 0.31), or at year 1 ( P  = 0.08). Mid‐buccal soft tissue recession changes did not differ by groups ( P  = 0.76). Successful treatment outcome (defect fill ≥1.0 mm, PPD values at implant ≤5 mm, no BOP , and no suppuration was identified in 1/20 (5.0%) control, and 9/21 (42.9%) test individuals ( F  = 7, 9, P  < 0.01). Number needed to treat analysis identified an absolute risk reduction of 32.8% in benefit of the test procedure. ( F  = 7, 9, P  < 0.01). Conclusions Successful treatment outcome using a bone substitute was more predictable when a composite therapeutic endpoint was considered.