San Diego. Researchers from the Departments of Periodontics at the University of Washington, the Michigan Center for Oral Health Research at the University of Michigan, private practices in Aurora, Co and Holmdel NJ in association with OraPharma, Inc, Warminster, PA, presented results from a multi-center study of Arrestin.
The authors begin by pointing out in the verbal presentation that recent studies have demonstrated an increasing prevalence of peri-implantitis. However, as they note, high-level evidence regarding treatment is sparse.
Given this, in association with the company that makes Arrestin, a protocol to evaluate the safety and efficacy of a locally administered antibiotic (LAA; ARESTIN®; Minocycline Hydrochloride Microspheres, 1 mg) for the adjunctive treatment of peri-implantitis was initiated in a 6-month, multi-center, single-blind, randomized, controlled clinical trial. Peri-implantitis was defined for purposes of this study as an implant site having the average of two probing depth (PD) measurements being at least 5mm with bleeding on probing (BOP) and radiographic evidence of bone loss.
All subjects were stratified by smoking status, received mechanical debridement and were randomly assigned to a control group (mechanical debridement only) or a test group (mechanical debridement plus LAA). For subjects in test group, a second application of LAA was given again at 3-month visit. PD and BOP were measured at baseline, 3 months and 6 months. Reductions from baseline in PD and % of BOP were analyzed using analysis of covariance.
The forty-four subjects were randomized into the study, 22 subjects in each group. Twenty subjects in control group and 22 subjects in test group completed study. At Day 90, PD reductions from baseline were 0.61mm and 1.04mm, respectively, (p=0.048) and % of BOP were reduced from baseline by 26.5% and 44.2%, respectively, (p=0.109). At Day 180, PD reductions from baseline were 0.78mm and 1.22mm, respectively, (p=0.079) and % of BOP were reduced from baseline by 35.5% and 62.9%, respectively, (p=0.018). There were no significant differences in incidence of adverse events between groups.
The authors conclude that the “promising” results suggest that further investigation of the safety and efficacy of LAA in the treatment of peri-implantitis is warranted. They also state that the treatment effect needs to be confirmed by conducting large confirmatory studies. The primary author of the study acknowledges he is an employee of OraPharma, Inc. ClinicalTrials.gov Identifier: NCT00662532. Study was funded by OraPharma, Inc., Warminster, PA.
