Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Minocycline HCl Microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis
Eligibility 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)
Sites / Locations
- University of Maryland, School of Dentistry
- Tufts University School of Dental Medicine
- University of Michigan - Michigan Center for Oral Health Research
- University of Missouri - Kansas City School of Dentistry Clinical Research Center
- University of North Carolina at Chapel Hill School of Dentistry
- University of Pennsylvania School of Dental Medicine
- Medical University of South Carolina College of Dental Medicine
- UTHSC - College of Dentistry
- Virginia Commonwealth University School of Dentistry
- Marquette University School of Dentstry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
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.
Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
Outcomes
Primary Outcome Measures
Change in mean Probing Depth of qualifying implant sites
Secondary Outcome Measures
Change in percentage of qualifying implants with Bleeding On Probing
Change in mean Probing Depth of qualifying implant sites
Change in percentage of qualifying implants with Bleeding on Probing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01517334
Brief Title
Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OraPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
Intervention Type
Drug
Intervention Name(s)
Minocycline HCl Microspheres
Other Intervention Name(s)
Arestin (brand name)
Primary Outcome Measure Information:
Title
Change in mean Probing Depth of qualifying implant sites
Time Frame
Baseline to Day 180
Secondary Outcome Measure Information:
Title
Change in percentage of qualifying implants with Bleeding On Probing
Time Frame
Baseline to Day 180
Title
Change in mean Probing Depth of qualifying implant sites
Time Frame
Baseline to Day 90
Title
Change in percentage of qualifying implants with Bleeding on Probing
Time Frame
Baseline to Day 90
Other Pre-specified Outcome Measures:
Title
Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)
Time Frame
Baseline to Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Offenbacher, DDS
Organizational Affiliation
University of North Carolina - Chapel Hill Dental School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, School of Dentistry
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan - Michigan Center for Oral Health Research
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Missouri - Kansas City School of Dentistry Clinical Research Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University of North Carolina at Chapel Hill School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Pennsylvania School of Dental Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina College of Dental Medicine
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
UTHSC - College of Dentistry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Virginia Commonwealth University School of Dentistry
City
Richmond
State/Province
Virginia
ZIP/Postal Code
98056
Country
United States
Facility Name
Marquette University School of Dentstry
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
12. IPD Sharing Statement
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Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
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