NCT01517334

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: OraPharma · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peri-Implantitis

Interventions

Type	Name	Description
DRUG	Minocycline HCl Microspheres

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2012-01-25
• Last updated: 2015-08-26

Locations

10 sites across 1 country: United States