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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
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
Change in mean Probing Depth of qualifying implant sites
Time frame: Baseline to Day 180
Change in percentage of qualifying implants with Bleeding On Probing
Time frame: Baseline to Day 180
Change in mean Probing Depth of qualifying implant sites
Time frame: Baseline to Day 90
Change in percentage of qualifying implants with Bleeding on Probing
Time frame: Baseline to Day 90
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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
UTHSC - College of Dentistry
Memphis, Tennessee, United States
Virginia Commonwealth University School of Dentistry
Richmond, Virginia, United States
Marquette University School of Dentstry
Milwaukee, Wisconsin, United States