Local Minocycline in Patients Under Supportive Periodontal Therapy

• Status: Completed
• Trial end date: 2019-10-18
• Target enrollment: 0
• Participant gender: All

Summary

The aims of the present study are to assess the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of the medication that is detected at 3 months during a 9-month period of regular SPT. Recurrent periodontitis will be defined as sites with residual periodontal probing depths and bleeding on probing after completion of initial periodontal therapy. This will include both persistent and recurrent periodontitis, where persistent means the residual periodontal site after initial periodontal therapy, and recurrent means the site which was improved by initial periodontal therapy, but disease recurred.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Dental Centre, Singapore
• Treatments: Minocycline

Criteria

Inclusion Criteria:

• Medically healthy adults (ASA classification I-II)

• At least 21 years of age.

• Previously diagnosed with moderate to severe periodontitis and had completed at least 1 round of periodontal therapy including scaling and root-planing, oral hygiene instructions.

• Treated periodontitis patients undergoing maintenance care for at least 6 months.

• Ability to comply with 12-month study follow-up.

• Recurrent moderate to severe periodontitis with no previous systemic antibiotic therapy during initial periodontal therapy.

• At least 4 teeth present with residual PPD of ≥ 5 mm on each and a positive bleeding on probing (BOP).

Exclusion Criteria:

• Medically compromised subjects (ASA classification III-V).

• Known allergy or other severe adverse reactions to minocycline and related drugs.

• Patients who reported local and/or systemic antibiotic therapy within 3 months prior to baseline examination of the study, and were placed on antibiotics during active initial periodontal therapy.

• Patients with a plaque control record > 30%.

• Patients who had history of surgical periodontal treatment less than 5 years in the area with lesions.

• Pregnant or intend to conceive or are breast feeding.