Arestin - Use in Subjects With Peri-Implantitis (Evaluation Excludes Changes in Subgingival Microflora)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/19/2013 |
| Start Date: | April 2012 |
| Contact: | Thomas Flemmig, DMD, MBA |
| Email: | flemmig@u.washington.edu |
| Phone: | 206-616-9671 |
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
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.
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)
We found this trial at
2
sites
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