Locally Delivered Minocycline in Advanced Periodontitis

NCT ID: NCT04076098

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2021-09-20

Brief Summary

Local drug delivery provides higher concentrations in the availability of the drug at the specific infected sites with the advantage of sustained release. Periocline is a long acting , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in an ointment containing microcapsule type particles. Periocline contains 20mg of minocycline in 0.5 gm of gel in a disposable polypropylene applicator (2% minocycline HCl).

Research has yielded promising results with the local application of minocycline in the treatment of periodontal disease, compared with other non-surgical therapies. However, there is scarcity of reports on the use of local delivery agents with respect to new range of putative pathogens in advanced periodontitis, wherein the tissue invasive anaerobic organisms are present and possibly compromised host response, hence resulting in an exaggerated breakdown of periodontal tissues at the affected sites. The effect of Minocycline on new putative pathogens, such as Filifactor alocis and oral phylotypes of phyla Synergistetes and TM7 (referred to hereafter as oral Synergistetes and oral TM7s), has not been investigated yet.

Hence, the aim of the present study is to evaluate the efficacy of a local delivery agent containing minocycline (Periocline, Sunstar, Japan) as an adjunct to SRP in the treatment of deep periodontal pockets around teeth in advanced periodontitis and the antimicrobial effect on the red complex and the new putative pathogens.

Detailed Description

The subjects for this randomized controlled, parallel arm study will be selected from the primary health care in the Faculty of Dentistry, MAHSA University. In this clinical trial, 50 patients with advanced periodontitis will be enrolled in the study.

Conditions

Periodontitis, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Minocycline

Minocycline gel

Group Type: EXPERIMENTAL

Minocycline Hydrochloride

Intervention Type: DRUG

Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets

Placebo

Similar gel without the active agent

Group Type: PLACEBO_COMPARATOR

Minocycline Hydrochloride

Intervention Type: DRUG

Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets

Interventions

Minocycline Hydrochloride

Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets

Intervention Type: DRUG

Other Intervention Names

Periocline

Eligibility Criteria

Inclusion Criteria

• systematically healthy patients with age range between 20- 60 years,
• diagnosed with untreated Advanced Periodontitis with a pocket depth ≥6mm around two or more teeth, in two or more quadrants.

Exclusion Criteria

• Patients given antibiotics or anti-inflammatory drugs in the past 6 months,
• allergic to tetracycline,
• pregnant or nursing females,
• those using chlorhexidine or any other mouth rinse

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahsa University

OTHER

Sponsor Role: lead

Responsible Party

Professor. Dr. Tara Bai Taiyeb Ali

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Taiyeb Ali, MSc, FDSRCS

Role: PRINCIPAL_INVESTIGATOR

Mahsa University

Locations

MAHSA University

Jenjarum, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

RP139-02/18

Identifier Type: -

Identifier Source: org_study_id