Surgical treatment of peri-implantitis with or without a deproteinized bovine bone mineral and a native bilayer collagen membrane: A randomized clinical trial

Aim To assess whether the use of deproteinized bovine bone mineral (DBBM) and native bilayer collagen membrane (NBCM) improved healing of peri-implantitis-related bone defects at 12 months. Materials and methods In a multi-centre, randomized clinical trial, 32 individuals received surgical debridement (control group [CG]), and 34 received adjunct use of DBBM and NBCM (test group [TG]). Radiographic defect fill (RDF), probing pocket depth (PPD), bleeding on probing (BOP), suppuration (SUP), recession (REC), cytokines (IL-1 beta, IL-1RA, IL-6, IL-8, IL-12, IP10, PDGF-BB, TNF-alpha, VEGF), and patient-reported outcomes (PROs) were evaluated at 3, 6, 9, and 12 months. Results RDF at the deepest site amounted 2.7 +/- 1.3 mm in TG and 1.4 +/- 1.2 mm in CG (p <.0001). PPD was reduced by 1.9 mm in TG and 2.3 mm in CG (p = .5783). There were no significant differences between groups regarding reductions of BOP, SUP, REC, cytokines levels, or oral health impact profile (OHIP)-14 scores at 12 months. Successful treatment (RDF >= 1.0 mm, PPD <= 5 mm, <= 1/4 site with BOP grade 1, no SUP) was identified in 32% in TG and 21% in CG. Conclusions DBBM and NBCM resulted in significantly more RDF than debridement alone. No difference was found in any clinical parameters or PROs between the groups. ClinicalTrials.gov Identifier: NCT02375750.

Automated summary

The use of DBBM and NBCM in addition to surgical debridement led to significantly more defect fill compared to debridement alone, but there were no significant differences in other clinical parameters or patient-reported outcomes between the two groups.