Arestin - Use in Subjects With Peri-Implantitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OraPharma
ClinicalTrials.gov Identifier:
NCT01539564
First received: February 21, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Peri-Implantitis
Drug: Minocycline HCl Microspheres
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

Resource links provided by NLM:


Further study details as provided by OraPharma:

Primary Outcome Measures:
  • Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 180 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in percentage of qualifying implants with Bleeding on Probing [ Time Frame: Baseline to Day 180 ] [ Designated as safety issue: No ]
  • Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 90 ] [ Designated as safety issue: No ]
  • Change in percentage of qualifying implants with Bleeding on Probing [ Time Frame: Baseline to Day 90 ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Arestin (brand name)
No Intervention: Control
Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539564

Locations
United States, California
UCLA School of Dentistry - Oral and Maxillofacial Surgery
Los Angeles, California, United States, 90095
United States, Florida
University of Florida College of Dentistry
Gainsville, Florida, United States, 32610
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Maryland
University of Maryland, School of Dentistry
Baltimore, Maryland, United States, 21201
United States, Minnesota
University of Minnesota - School of Dentistry
Minneapolis, Minnesota, United States, 55355
United States, North Carolina
University of North Carolina, General Oral Health Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University College of Dentistry
Columbus, Ohio, United States, 43210
United States, Virginia
The Periodontal-Implant Institute
McLean, Virginia, United States, 22101
United States, Washington
University of Washington, School of Dentistry
Seattle, Washington, United States, 98195-7444
Germany
University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie
Dusseldorf, Germany, 40225
Sweden
Kristianstad University, Department of Periodontology
Kristianstad, Sweden, SE-291 88
United Kingdom
Eastman Dental Institute, University College of London
London, United Kingdom, WC1X 8LD
Sponsors and Collaborators
OraPharma
Investigators
Principal Investigator: Thomas Flemmig, DMD, MBA University of Washington, School of Dentistry
  More Information

No publications provided

Responsible Party: OraPharma
ClinicalTrials.gov Identifier: NCT01539564     History of Changes
Other Study ID Numbers: OP-P-5267
Study First Received: February 21, 2012
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014