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Completed

NCT Number: NCT00762762

Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population

Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of >200mg/dl.
  • Minimum of 16 teeth
  • Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6 teeth

Exclusion criteria

  • Any condition requiring antibiotic cover for dental treatment
  • Other serious illness

Treatment and study plan

Triclosan/copolymer/fluoride

Drug

Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Other names: Total toothpaste

Fluoride

Drug

Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Other names: Fluorigard oral rinse

Primary outcomes

  1. HbA1c Levels in Blood

    Time frame: 12 months

    Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.

  2. High Sensitivity CRP (C-Reactive Protein)

    Time frame: 12 months

    CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.

  3. C-Peptide

    Time frame: 12 months

    C-Peptide levels in blood indicate whether or not a person is producing insulin

  4. IL-6 (Interleukin - 6)

    Time frame: 12 months

    Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms)

  5. TNF-α (Tumor Necrosis Factor - Alpha)

    Time frame: 12 months

    Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Mar 3, 2023

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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