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OpenTrials
Completed

NCT Number: NCT00763256

The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics

To test effectiveness of dentifrice in maintaining periodontal health.

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Logan Hospital Oral Health Clinic

Queensland, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Poor glycaemic control as evidenced by an HbA1c of >6.0% for the past 12 months
  • Aged 18 to 75 years
  • Able to give informed consent
  • Minimum of 12 teeth
  • Chronic periodontitis as indicated by periodontal probing depths >5mm on at least 6 teeth

Exclusion criteria

  • Pregnancy
  • Gross dental caries
  • Prosthetic heart valves, a history of infective endocarditis or any other condition requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve prolapse with regurgitation)
  • Anticoagulant therapy (excluding asprin)

Treatment and study plan

Triclosan, fluoride

Drug

subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.

Other names: triclosan/fluoride/copolymer toothpaste

Fluoride

Drug

subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Other names: current marketed fluoride only toothpaste

Primary outcomes

  1. HbA1c Levels in Blood

    Time frame: 12 months

    Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).

  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. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).

  3. C-Peptide

    Time frame: 12 months

    C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).

  4. Gingivitis Score (GI)

    Time frame: 12 months

    Units on a scale 0 to 3 (0 = no inflammation,

    1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  5. P. Gingivalis

    Time frame: 12 months

    Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2008
Registry last updated
Jul 28, 2015

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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