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

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

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 Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Drug: Minocycline HCl Microspheres

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, School of Dentistry
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan - Michigan Center for Oral Health Research
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • University of Missouri - Kansas City School of Dentistry Clinical Research Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill School of Dentistry
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania School of Dental Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina College of Dental Medicine
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • UTHSC - College of Dentistry
  • Virginia
    • Richmond, Virginia, United States, 98056
      • Virginia Commonwealth University School of Dentistry
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Marquette University School of Dentstry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.	Drug: Minocycline HCl Microspheres; Other Names: Arestin (brand name)
No Intervention: Control; Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean Probing Depth of qualifying implant sites	Baseline to Day 180

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in percentage of qualifying implants with Bleeding On Probing	Baseline to Day 180
Change in mean Probing Depth of qualifying implant sites	Baseline to Day 90
Change in percentage of qualifying implants with Bleeding on Probing	Baseline to Day 90

Other Outcome Measures

Outcome Measure	Time Frame
Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)	Baseline to Day 30

Collaborators and Investigators

• Sponsor: OraPharma
• Investigators: Principal Investigator: Steven Offenbacher, DDS, University of North Carolina - Chapel Hill Dental School

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: OP-P-5266-M