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NCT Number: NCT04076098

Locally Delivered Minocycline in Advanced Periodontitis

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.

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Key information

Conditions

Periodontitis, Adult Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MAHSA University

Jenjarum, Selangor, 42610, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minocycline Hydrochloride

Drug

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

Other names: Periocline

Primary outcomes

  1. Change in Probing pocket depth (PPD)

    Time frame: baseline to 12 weeks

    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.

  2. Change in the numbers of Periodontal pathogens

    Time frame: baseline to 12 weeks

    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

  3. Clinical Attachment Levels (CAL)

    Time frame: baseline, 6 weeks and 12 weeks

    change in CAL

Secondary outcomes

  1. Plaque Index

    Time frame: baseline to 12 weeks

    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.

  2. Bleeding Index

    Time frame: baseline to 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mahsa University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 3, 2019
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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