Who is sponsoring NCT01517334?

NCT01517334 is sponsored by OraPharma.

What condition does NCT01517334 study?

NCT01517334 studies Peri-Implantitis.

What drugs are being tested in NCT01517334?

Interventions: Minocycline HCl Microspheres.

What is the status of NCT01517334?

NCT01517334 is currently COMPLETED.

Last reviewed 2015-08-25 · How we verify

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

NCT01517334 Phase 3 COMPLETED

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.

Details

Lead sponsor	OraPharma
Phase	Phase 3
Status	COMPLETED
Enrolment	208
Start date	2012-05
Completion	2014-11

Conditions

Peri-Implantitis

Interventions

Minocycline HCl Microspheres

Primary outcomes

Change in mean Probing Depth of qualifying implant sites — Baseline to Day 180

Countries

United States