Arestin - Use in Subjects With Peri-Implantitis (Evaluation Excludes Changes in Subgingival Microflora)
This study is currently recruiting participants.
Verified May 2012 by OraPharma
Sponsor:
OraPharma
Information provided by (Responsible Party):
OraPharma
ClinicalTrials.gov Identifier:
NCT01539564
First received: February 21, 2012
Last updated: May 1, 2012
Last verified: May 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Peri-Implantitis |
Drug: Minocycline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) 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:
- Reduction of Probing Depth [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]The primary efficacy measure is the reduction of probing depth from Baseline to Day 180 of qualifying implant sites.
Secondary Outcome Measures:
- Reduction of Bleeding on Probing [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
- Reduction of Probing Depth and Bleeding on Probing [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 215 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arestin
Active Treatment
|
Drug: Minocycline
Microspheres 1 mg
|
| No Intervention: 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 8mm (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539564
Contacts
| Contact: Thomas Flemmig, DMD, MBA | 206-616-9671 | flemmig@u.washington.edu |
Locations
| United States, Virginia | |
| The Periodontal-Implant Institute | Recruiting |
| McLean, Virginia, United States, 22101 | |
| Contact: Lillian C Carpio, DDS, MS, PhD 703-288-3570 | |
| Principal Investigator: Lillian C Carpio, DDS, MS, PhD | |
| United States, Washington | |
| University of Washington, School of Dentistry | Not yet recruiting |
| Seattle, Washington, United States, 98195-7444 | |
| Contact: Thomas Flemmig, DMD, MBA 206-616-9671 flemmig@u.washington.edu | |
| Principal Investigator: Thomas Flemmig, DMD, MBA | |
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: | May 1, 2012 |
| 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 May 19, 2013