Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
Information source: OraPharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peri-Implantitis
Intervention: Minocycline HCl Microspheres (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: OraPharma Official(s) and/or principal investigator(s): Steven Offenbacher, DDS, Principal Investigator, Affiliation: University of North Carolina - Chapel Hill Dental School
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in mean Probing Depth of qualifying implant sites
Secondary outcome: Change in percentage of qualifying implants with Bleeding On ProbingChange in mean Probing Depth of qualifying implant sites Change in percentage of qualifying implants with Bleeding on Probing
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
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
Additional Information
Starting date: May 2012
Last updated: April 7, 2014
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