Arestin - Use in Subjects With Peri-Implantitis

Peri-Implantitis Clinical Trial

Official title:

Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539564
• Other study ID #: OP-P-5267
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2012
• Last updated: June 25, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: OraPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Drug:
• Minocycline HCl Microspheres

Locations

Country	Name	City	State
Germany	University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie	Dusseldorf
Sweden	Kristianstad University, Department of Periodontology	Kristianstad
United Kingdom	Eastman Dental Institute, University College of London	London
United States	Georgia Regents University	Augusta	Georgia
United States	University of Maryland, School of Dentistry	Baltimore	Maryland
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	University of Florida College of Dentistry	Gainsville	Florida
United States	UCLA School of Dentistry - Oral and Maxillofacial Surgery	Los Angeles	California
United States	The Periodontal-Implant Institute	McLean	Virginia
United States	University of Minnesota - School of Dentistry	Minneapolis	Minnesota
United States	University of Washington, School of Dentistry	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
OraPharma

Countries where clinical trial is conducted

United States,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean Probing Depth of qualifying implant sites		Baseline to Day 180	No
Secondary	Change in percentage of qualifying implants with Bleeding on Probing		Baseline to Day 180	No
Secondary	Change in mean Probing Depth of qualifying implant sites		Baseline to Day 90	No
Secondary	Change in percentage of qualifying implants with Bleeding on Probing		Baseline to Day 90	No