Locally Delivered Minocycline in Advanced Periodontitis

NCT04076098 | Completed Phase 4 DMC

• 1 other identifier: RP139-02/18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Adult

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Plaque Index

  baseline to 12 weeks

• Bleeding Index

  baseline to 12 weeks

Study Arms (2)

Minocycline

EXPERIMENTAL

Minocycline gel

Drug: Minocycline Hydrochloride

Placebo

PLACEBO COMPARATOR

Similar gel without the active agent

Drug: Minocycline Hydrochloride

Interventions

Minocycline Hydrochloride DRUG

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

Also known as: Periocline

Minocycline; Placebo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahsa University: lead

Study Sites (1)

MAHSA University

Jenjarum, Selangor, 42610, Malaysia

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Minocycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Tara Taiyeb Ali, MSc, FDSRCS

  Mahsa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: September 3, 2019
• Study Start: June 25, 2018
• Primary Completion: December 28, 2020
• Study Completion: September 20, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)