drugset / Trial / NCT01539564

Arestin - Use in Subjects With Peri-Implantitis

NCT01539564

Phase 3 Completed 215 enrolled OraPharma
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement. The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.

Timeline

Start
2012-04
Primary completion
2014-05
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Minocycline Small molecule 1 mg

Indications