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

Study Overview
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Brief Summary
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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.

Official Title
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Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Drug: Minocycline HCl Microspheres


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment (minocycline HCl microspheres, 1mg) administered at Baseline (following randomization) and Day 90 to qualifying implant sites, plus full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180. | Drug: Minocycline HCl Microspheres<br> <br> * Other names: Arestin (brand name);|
| No Intervention: Control<br>Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Probing Depth of qualifying implant sites |  | Baseline to Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |