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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
UCLA School of Dentistry - Oral and Maxillofacial Surgery
Los Angeles, California, United States
University of Florida College of Dentistry
Gainsville, Florida, United States
Georgia Regents University
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Augusta, Georgia, United States
University of Maryland, School of Dentistry
Baltimore, Maryland, United States
University of Minnesota - School of Dentistry
Minneapolis, Minnesota, United States
University of North Carolina, General Oral Health Center
Chapel Hill, North Carolina, United States
Ohio State University College of Dentistry
Columbus, Ohio, United States
The Periodontal-Implant Institute
McLean, Virginia, United States
University of Washington, School of Dentistry
Seattle, Washington, United States
University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie
Düsseldorf, Germany
...and 2 more locations