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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763256
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 2, 2012
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Description
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Brief Summary:
To test effectiveness of dentifrice in maintaining periodontal health.

Condition or disease Intervention/treatment Phase
Periodontal Disease Drug: Triclosan, Fluoride Drug: Fluoride Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Study Start Date : May 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: Triclosan, Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
Other Name: triclosan/fluoride/copolymer toothpaste
Placebo Comparator: B Drug: Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
Other Name: current marketed fluoride only toothpaste


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763256


Locations
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Australia
Logan Hospital Oral Health Clinic
Queensland, Australia
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Gregory Seymour, BDS University of Otago
More Information
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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00763256    
Other Study ID Numbers: 2004000841/2004/201
First Posted: September 30, 2008    Key Record Dates
Results First Posted: April 2, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Triclosan
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
 Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents