Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
- Registration Number
- NCT01517334
- Lead Sponsor
- OraPharma
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Minocycline HCl Microspheres 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.
- Primary Outcome Measures
Name Time Method Change in mean Probing Depth of qualifying implant sites Baseline to Day 180
- Secondary Outcome Measures
Name Time Method Change in percentage of qualifying implants with Bleeding On Probing Baseline to Day 180 Change in percentage of qualifying implants with Bleeding on Probing Baseline to Day 90 Change in mean Probing Depth of qualifying implant sites Baseline to Day 90
Trial Locations
- Locations (10)
UTHSC - College of Dentistry
🇺🇸Memphis, Tennessee, United States
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
Virginia Commonwealth University School of Dentistry
🇺🇸Richmond, Virginia, United States
Marquette University School of Dentstry
🇺🇸Milwaukee, Wisconsin, United States