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NCT01517334 · ClinicalTrials.gov registry record · Phase 3
Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
A Phase 3 study of Peri Implantitis, sponsored by OraPharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
- 10
- Study locations
NCT01517334: Completed Phase 3 study of Peri Implantitis, sponsored by OraPharma.
NCT01517334 is a Phase 3 study of Peri Implantitis that has completed, run by OraPharma. The registered enrollment target is 208 participants, above the 68-participant average among 4 other Peri Implantitis trials with a reported enrollment target (206% higher). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01517334, a Phase 3 study of Peri Implantitis, has completed, sponsored by OraPharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
- 10
- Study locations
Study 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 Studied
Interventions
- DRUG Minocycline HCl Microspheres
Study Locations (10)
Maryland
- University of Maryland, School of Dentistry - Baltimore
Massachusetts
- Tufts University School of Dental Medicine - Boston
Michigan
- University of Michigan - Michigan Center for Oral Health Research - Ann Arbor
Missouri
- University of Missouri - Kansas City School of Dentistry Clinical Research Center - Kansas City
North Carolina
- University of North Carolina at Chapel Hill School of Dentistry - Chapel Hill
Pennsylvania
- University of Pennsylvania School of Dental Medicine - Philadelphia
South Carolina
- Medical University of South Carolina College of Dental Medicine - Charleston
Tennessee
- UTHSC - College of Dentistry - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01517334 record still lists
NCT01517334 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 68-participant average among 4 other Peri Implantitis trials with a reported enrollment target (206% higher).
The record links to 1 condition, with Peri Implantitis appearing as the primary indexed condition, and to 1 intervention - of which Minocycline HCl Microspheres is the first listed.
NCT01517334 lists 10 locations in 10 states (Maryland, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT01517334 about?
NCT01517334 is a clinical study titled "Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)". 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 comb...
What is the current status of trial NCT01517334?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2012-05. Estimated completion is 2014-11.
What conditions does trial NCT01517334 study?
This clinical trial studies the following conditions: Peri Implantitis.
What interventions are being tested in trial NCT01517334?
The interventions under investigation include: Minocycline HCl Microspheres (DRUG).
Who is sponsoring clinical trial NCT01517334?
This trial is sponsored by OraPharma, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01517334 being conducted?
This trial has 10 study locations across Maryland, Massachusetts, Michigan, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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