drugset / Trial / NCT01517334

Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)

NCT01517334

Phase 3 Completed 208 enrolled OraPharma
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of the study is to evaluate the safety, effectiveness and anti-microbial effects 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
2012-05
Primary completion
2014-09
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Minocycline Small molecule 1 mg

Indications