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

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ClinicalTrials.gov Identifier: NCT01517334
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
OraPharma

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Peri-Implantitis Drug: Minocycline HCl Microspheres Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

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U.S. FDA Resources

Arms and Interventions
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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 Name: Arestin (brand name)
No Intervention: Control
Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment


Outcome Measures
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Primary Outcome Measures :
  1. Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 180 ]

Secondary Outcome Measures :
  1. Change in percentage of qualifying implants with Bleeding On Probing [ Time Frame: Baseline to Day 180 ]
  2. Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 90 ]
  3. Change in percentage of qualifying implants with Bleeding on Probing [ Time Frame: Baseline to Day 90 ]

Other Outcome Measures:
  1. Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB) [ Time Frame: Baseline to Day 30 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517334


Locations
United States, Maryland
University of Maryland, School of Dentistry
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan - Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
United States, Missouri
University of Missouri - Kansas City School of Dentistry Clinical Research Center
Kansas City, Missouri, United States, 64108
United States, North Carolina
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina College of Dental Medicine
Charleston, South Carolina, United States, 29403
United States, Tennessee
UTHSC - College of Dentistry
Memphis, Tennessee, United States, 38163
United States, Virginia
Virginia Commonwealth University School of Dentistry
Richmond, Virginia, United States, 98056
United States, Wisconsin
Marquette University School of Dentstry
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
OraPharma
Investigators
Principal Investigator: Steven Offenbacher, DDS University of North Carolina - Chapel Hill Dental School
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: OraPharma
ClinicalTrials.gov Identifier: NCT01517334     History of Changes
Other Study ID Numbers: OP-P-5266-M
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: April 2014

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