Arestin - Use in Subjects With Peri-Implantitis
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
1 other identifier
interventional
215
4 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2012
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 26, 2014
June 1, 2014
2.1 years
February 21, 2012
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in mean Probing Depth of qualifying implant sites
Baseline to Day 180
Secondary Outcomes (3)
Change in percentage of qualifying implants with Bleeding on Probing
Baseline to Day 180
Change in mean Probing Depth of qualifying implant sites
Baseline to Day 90
Change in percentage of qualifying implants with Bleeding on Probing
Baseline to Day 90
Study Arms (2)
Treatment
EXPERIMENTALTreatment (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.
Control
NO INTERVENTIONFull-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OraPharmalead
Study Sites (12)
UCLA School of Dentistry - Oral and Maxillofacial Surgery
Los Angeles, California, 90095, United States
University of Florida College of Dentistry
Gainsville, Florida, 32610, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
University of Maryland, School of Dentistry
Baltimore, Maryland, 21201, United States
University of Minnesota - School of Dentistry
Minneapolis, Minnesota, 55355, United States
University of North Carolina, General Oral Health Center
Chapel Hill, North Carolina, 27599, United States
Ohio State University College of Dentistry
Columbus, Ohio, 43210, United States
The Periodontal-Implant Institute
McLean, Virginia, 22101, United States
University of Washington, School of Dentistry
Seattle, Washington, 98195-7444, United States
University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie
Düsseldorf, 40225, Germany
Kristianstad University, Department of Periodontology
Kristianstad, SE-291 88, Sweden
Eastman Dental Institute, University College of London
London, WC1X 8LD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Flemmig, DMD, MBA
University of Washington, School of Dentistry
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2012
First Posted
February 27, 2012
Study Start
April 1, 2012
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
June 26, 2014
Record last verified: 2014-06