NCT01539564

Arestin - Use in Subjects With Peri-Implantitis

Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: OraPharma · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peri-Implantitis

Interventions

Type	Name	Description
DRUG	Minocycline HCl Microspheres

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2012-02-27
• Last updated: 2014-06-26

Locations

12 sites across 4 countries: United States, Germany, Sweden, United Kingdom