Overview

Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OraPharma
Treatments:
Minocycline
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)