Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
215 participants
INTERVENTIONAL
2012-04-30
2014-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Treatment (minocycline HCl microspheres, 1mg) administered at Baseline (following randomization) and Day 90 to qualifying implant sites, plus full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180.
Minocycline HCl Microspheres
Control
Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
No interventions assigned to this group
Interventions
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Minocycline HCl Microspheres
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
21 Years
ALL
No
Sponsors
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OraPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Flemmig, DMD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Washington, School of Dentistry
Locations
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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
Countries
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Other Identifiers
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OP-P-5267
Identifier Type: -
Identifier Source: org_study_id
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