Arestin - Use in Subjects With Peri-Implantitis

Completed · Phase 3

Conditions studied: Peri-Implantitis

In brief

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.

Key facts

Study ID

NCT01539564

Run by

OraPharma

People needed

215

Starts

2012-04-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A minimum of one osseointegrated implant with a diagnosis of peri-implantitis
• Absence of any significant oral soft tissue pathology
• At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing
• Confirmed evidence of pathologic bone loss
• At least 1mm of keratinized gingiva present around the implant

You may not qualify if…

• Pregnancy
• Allergy to tetracycline-class drug(s)
• Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures
• Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis
• Diagnosis of clinically significant or unstable organic disease, or compromised healing potential
• Signs of untreated advanced periodontal disease and/or poor oral hygiene
• Subjects having a probing depth greater than 8mm at time of enrollment
• Subjects presenting with mobility of any dental implant
• Subjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)

Where it is running

• UCLA School of Dentistry - Oral and Maxillofacial Surgery — Los Angeles, California, United States
• University of Florida College of Dentistry — Gainsville, Florida, United States
• Georgia Regents University — Augusta, Georgia, United States
• University of Maryland, School of Dentistry — Baltimore, Maryland, United States
• University of Minnesota - School of Dentistry — Minneapolis, Minnesota, United States
• University of North Carolina, General Oral Health Center — Chapel Hill, North Carolina, United States
• Ohio State University College of Dentistry — Columbus, Ohio, United States
• The Periodontal-Implant Institute — McLean, Virginia, United States
• University of Washington, School of Dentistry — Seattle, Washington, United States
• University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie — Düsseldorf, Germany
• Kristianstad University, Department of Periodontology — Kristianstad, Sweden
• Eastman Dental Institute, University College of London — London, United Kingdom

Full record on ClinicalTrials.gov

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