Clinical trial NCT04076098: Locally Delivered Minocycline in Advanced Periodontitis
Official title: Efficacy of Locally Delivered Minocycline in Advanced Periodontitis. A Clinico-microbiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis, Adult
Lead sponsor: Mahsa University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Probing pocket depth (PPD)
timeFrame: baseline to 12 weeks
measure: Change in the numbers of Periodontal pathogens
timeFrame: baseline to 12 weeks
measure: Clinical Attachment Levels (CAL)
timeFrame: baseline, 6 weeks and 12 weeks
Secondary outcomes:
measure: Plaque Index
timeFrame: baseline to 12 weeks
measure: Bleeding Index
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Jenjarum
country: Malaysia
facility: MAHSA University
state: Selangor
Study officials:
affiliation: Mahsa University
name: Tara Taiyeb Ali, MSc, FDSRCS
role: PRINCIPAL_INVESTIGATOR
References: