Status:
COMPLETED
Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
Lead Sponsor:
OraPharma
Conditions:
Peri-Implantitis
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
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 u...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT01517334
Start Date
May 1 2012
End Date
November 1 2014
Last Update
August 26 2015
Active Locations (10)
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1
University of Maryland, School of Dentistry
Baltimore, Maryland, United States, 21201
2
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
3
University of Michigan - Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
4
University of Missouri - Kansas City School of Dentistry Clinical Research Center
Kansas City, Missouri, United States, 64108