Local Minocycline in Patients Under Supportive Periodontal Therapy

NCT04036890 | Completed Phase 4

• 1 other identifier: 196/2014
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontitis

Keywords

Recurrent periodontitis; Periodontal therapy

Outcome Measures

Primary Outcomes (1)

• Absolute change of probing pocket depth (PPD)

  Absolute change of PPD at 3 months compared to baseline is defined as the difference between absolute patient PPD at 3 months and absolute patient PPD at baseline. For patients who have multiple trial sites, the mean of site absolute PPD will be used as their patient PPD score.

  3 months

Secondary Outcomes (5)

• Absolute change of probing pocket depth (PPD)

  6, 9,12 months

• Percentage reduction of number of probing pocket depth (PPD) ≥ 5 mm

  3, 6, 9,12 months

• Reduction in bleeding on probing (BOP)

  3 months vs baseline, 6 months vs baseline, 9 months vs baseline, 12 months vs baseline, 3 months vs 6 months, 3 months vs 6 months, 3 months vs 9 months, and 3 months vs 12 months.

• Change of probing attachment level (PAL)

  3, 6, 9,12 months

• Incidence of recurrent rate during experimental period.

  3, 6, 9,12 months

Study Arms (2)

2% minocycline hydrochloride controlled-delivery system (MHS)

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

2% minocycline hydrochloride controlled-delivery system (MHS) DRUG

The test product is a highly viscous gel for local subgingival placement composing of an ointment containing micro-capsule type particles for sustained release and the active ingredient 2% minocycline gel (10mg in each syringe of 0.5g) (Periocline, SUNSTAR, Osaka, Japan). The other ingredients include magnesium chloride, hydroxyl-ethylcellulose, aminoalkylmethacrylaye copolymer, triacetin and concentrated glycerine, giving the preparation a sustained-released property. It will be applied to experimental teeth and the adjacent teeth by gently inserting the tip of a specially designed applicator until the paste flows over the gingival margin.

2% minocycline hydrochloride controlled-delivery system (MHS)

Placebos DRUG

It is the same gel as MHS but without active ingredient minocycline hydrochloride.

Placebo

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Dental Centre, Singapore: lead

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The examiners (PI and Outcomes Assessors) will be blinded during the clinical examination of the patients. The topical antibiotic will be administered by a trained and delegated clinician who is not involved in the outcome assessment. Patients will be blinded to their treatment group as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Consultant

Model Details: Randomised, double blinded trial in parallel group

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 30, 2019
• Study Start: June 3, 2016
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11