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

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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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Seattle, WA
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McLean, Virginia 22101
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McLean, VA
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