Arestin - Use in Subjects With Peri-Implantitis

Phase 3

Completed

• Conditions: Peri-Implantitis
• Interventions: Drug: Minocycline HCl Microspheres

• Registration Number: NCT01539564
• Lead Sponsor: OraPharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-27
• Study Start: 2012-04
• Primary Completion: 2014-05
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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)

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 90
Change in mean Probing Depth of qualifying implant sites	Baseline to Day 90

Trial Locations

Locations (12)

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; 🇺🇸 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; 🇩🇪 Dusseldorf, Germany

Scroll for more (2 remaining)