Arestin - Use in Subjects With Peri-Implantitis

OraPharma

Status and phase: Completed; Phase 3

Conditions: Peri-Implantitis

Treatments: Drug: Minocycline HCl Microspheres

Study type: Interventional

Funder types: Industry

Identifiers

NCT01539564

OP-P-5267

Details and patient eligibility

About

The objective of the study is to evaluate the safety and effectiveness 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.

Enrollment: 215 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Drug: Minocycline HCl Microspheres

Control

No Intervention group

Description:

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