AIM: To assess whether the treatment outcome differed between surgical debridement, with or without a bone substitute.

MATERIALS AND METHODS: 41 adults with 3 or 4 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 (χ2=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. This article is protected by copyright. All rights reserved.