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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-11-30

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.

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Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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.

Group Type EXPERIMENTAL

Minocycline HCl Microspheres

Intervention Type DRUG

Control

Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Minocycline HCl Microspheres

Intervention Type DRUG

Other Intervention Names

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Arestin (brand name)

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)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No