Locally Delivered Minocycline in Advanced Periodontitis

Efficacy of Locally Delivered Minocycline in Advanced Periodontitis. A Clinico-microbiological Study

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis, Adult
• Intervention / Treatment: Drug: Minocycline Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Jenjarum, Selangor, Malaysia, 42610
      • Mahsa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minocycline; Minocycline gel	Drug: Minocycline Hydrochloride; Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets; Other Names: Periocline
Placebo Comparator: Placebo; Similar gel without the active agent	Drug: Minocycline Hydrochloride; Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets; Other Names: Periocline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing pocket depth (PPD)	Periodontal pocket is measured from the gingival margin to the base of the periodontal pocket using a UNC periodontal probe (which is graduated from 1mm to 15mm). The measurement of periodontal pocket depth is a continuous scale. PPD is taken at 6 points on each tooth. The mean of the PPD will be obtained for each patient and subjected to statistical analysis.	baseline to 12 weeks
Change in the numbers of Periodontal pathogens	Plaque samples taken from periodontal pockets on paper points will be first stored and later analysed for the presence and number of periopathogens using quantative Polymerase Chain Reaction (q-PCR). The following periodontal pathogens will be assessed: Red complex (Porphyromonas gingivalis, Tannerella forsythia,and Treponema denticola); Filifactor alocis,; oral phylotypes of phyla Synergistetes; Phylum TM7	baseline to 12 weeks
Clinical Attachment Levels (CAL)	change in CAL	baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index	change in Plaque scores (Silness and Loe Plaque index, 1964) The score ranges from 0-3 and it is a continuous scale. '0' - no plaque '1' - thin plaque which is not visible by naked eye '2' - Moderate accumulation plaque seen by naked eye '3' - abundance of plaque. Calculation total score /number of surfaces examined = Index score for each patient. Mean plaque score is calculated for all the patients.	baseline to 12 weeks
Bleeding Index	change in Bleeding scores (Papillary bleeding index, Muehlemann 1977) The score ranges from 0-4 and it is a continuous scale. '0' - no bleeding '1' - Single discrete bleeding point '2' - Single line of blood appears '3' - Interdental papilla fills with blood after probing '4' - profuse bleeding after probing Calculation total score /number of surfaces examined = Index score for each patient. Mean plaque score is calculated for all the patients.	baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Mahsa University
• Investigators: Principal Investigator: Tara Taiyeb Ali, MSc, FDSRCS, Mahsa University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: RP139-02/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No