Peri-Implantitis
Conditions
Brief 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.
Interventions
Sponsors
OraPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean Probing Depth of qualifying implant sites | Baseline to Day 180 |
Secondary
| Measure | Time frame |
|---|---|
| Change in percentage of qualifying implants with Bleeding On Probing | Baseline to Day 180 |
| Change in mean Probing Depth of qualifying implant sites | Baseline to Day 90 |
| Change in percentage of qualifying implants with Bleeding on Probing | Baseline to Day 90 |
Other
| Measure | Time frame |
|---|---|
| Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB) | Baseline to Day 30 |
Countries
United States
Outcome results
None listed