Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
Completed · Phase 3
Conditions studied: Peri-Implantitis
In brief
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.
Key facts
- Study ID
- NCT01517334
- Run by
- OraPharma
- People needed
- 208
- Starts
- 2012-05-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2015-08-26
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
- University of Maryland, School of Dentistry — Baltimore, Maryland, United States
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States
- University of Michigan - Michigan Center for Oral Health Research — Ann Arbor, Michigan, United States
- University of Missouri - Kansas City School of Dentistry Clinical Research Center — Kansas City, Missouri, United States
- University of North Carolina at Chapel Hill School of Dentistry — Chapel Hill, North Carolina, United States
- University of Pennsylvania School of Dental Medicine — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina College of Dental Medicine — Charleston, South Carolina, United States
- UTHSC - College of Dentistry — Memphis, Tennessee, United States
- Virginia Commonwealth University School of Dentistry — Richmond, Virginia, United States
- Marquette University School of Dentstry — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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