Arestin - Use in Subjects With Peri-Implantitis
Information source: OraPharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peri-Implantitis
Intervention: Minocycline HCl Microspheres (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: OraPharma Official(s) and/or principal investigator(s): Thomas Flemmig, DMD, MBA, Principal Investigator, Affiliation: University of Washington, School of Dentistry
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.
Clinical Details
Official title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in mean Probing Depth of qualifying implant sites
Secondary outcome: Change in percentage of qualifying implants with Bleeding on ProbingChange in mean Probing Depth of qualifying implant sites Change in percentage of qualifying implants with Bleeding on Probing
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Locations and Contacts
University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie, Dusseldorf 40225, Germany
Kristianstad University, Department of Periodontology, Kristianstad SE-291 88, Sweden
Eastman Dental Institute, University College of London, London WC1X 8LD, United Kingdom
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
Additional Information
Starting date: April 2012
Last updated: June 25, 2014
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