Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517334
• Other study ID #: OP-P-5266-M
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2012
• Last updated: August 25, 2015
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: April 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: November 2014
• Est. primary completion date: September 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
United States	University of Michigan - Michigan Center for Oral Health Research	Ann Arbor	Michigan
United States	University of Maryland, School of Dentistry	Baltimore	Maryland
United States	Tufts University School of Dental Medicine	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill School of Dentistry	Chapel Hill	North Carolina
United States	Medical University of South Carolina College of Dental Medicine	Charleston	South Carolina
United States	University of Missouri - Kansas City School of Dentistry Clinical Research Center	Kansas City	Missouri
United States	UTHSC - College of Dentistry	Memphis	Tennessee
United States	Marquette University School of Dentstry	Milwaukee	Wisconsin
United States	University of Pennsylvania School of Dental Medicine	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University School of Dentistry	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
OraPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)		Baseline to Day 30	No
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