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
1 other identifier
interventional
208
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2012
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedAugust 26, 2015
April 1, 2014
2.3 years
January 10, 2012
August 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in mean Probing Depth of qualifying implant sites
Baseline to Day 180
Secondary Outcomes (3)
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 Outcomes (1)
Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)
Baseline to Day 30
Study Arms (2)
Treatment
EXPERIMENTALTreatment (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.
Control
NO INTERVENTIONFull-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OraPharmalead
Study Sites (10)
University of Maryland, School of Dentistry
Baltimore, Maryland, 21201, United States
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
University of Michigan - Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106, United States
University of Missouri - Kansas City School of Dentistry Clinical Research Center
Kansas City, Missouri, 64108, United States
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina College of Dental Medicine
Charleston, South Carolina, 29403, United States
UTHSC - College of Dentistry
Memphis, Tennessee, 38163, United States
Virginia Commonwealth University School of Dentistry
Richmond, Virginia, 98056, United States
Marquette University School of Dentstry
Milwaukee, Wisconsin, 53233, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Offenbacher, DDS
University of North Carolina - Chapel Hill Dental School
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 25, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2014
Study Completion
November 1, 2014
Last Updated
August 26, 2015
Record last verified: 2014-04