Local Minocycline in Patients Under Supportive Periodontal Therapy

National Dental Centre, Singapore

Status and phase: Completed; Phase 4

Conditions: Periodontitis

Treatments: Drug: Placebos; Drug: 2% minocycline hydrochloride controlled-delivery system (MHS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04036890

196/2014

Details and patient eligibility

About

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.

Full description

It has been reported that regular maintenance of subjects with treated periodontal disease is the key consideration in the long-term periodontal prognosis of these subjects. Periodic prophylaxis may prevent loss of clinical attachment over long periods of time even in patients with less than optimal plaque control. However, there are limitations in routine subgingival re-instrumentation especially in bleeding pockets, as only 50% of these sites improve. Furthermore, the persistence of bleeding pockets increases the risk of disease progression and tooth loss. Thus there is a need for adjuncts that may improve the outcome especially in subjects with recurrent periodontitis during SPT. Some studies reported significantly better results with subgingival administration of local minocycline in residual pockets post initial periodontal therapy over a short period of time. There are few studies assessing the efficacy of topical minocycline gel in subjects with recurrent periodontitis while in SPT, and the long term effect.

The present study will examine 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 will be detected at 3 months during a 9-month period of regular SPT.

Enrollment: 68 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

2% minocycline hydrochloride controlled-delivery system (MHS)

Experimental group

Description:

Mechanical ultrasonic/ hand instrumentation and subsequent administration of MHS on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months

Treatment:

Drug: 2% minocycline hydrochloride controlled-delivery system (MHS)

Placebo

Placebo Comparator group

Description:

Mechanical ultrasonic/ hand instrumentation and subsequent administration of a placebo gel on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months

Treatment:

Drug: Placebos