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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000260628 |
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Date of registration:
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02/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Diabetes after Periodontal Treatment
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Scientific title:
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The effect of periodontal treatment and the use of a triclosan dentifrice on glycaemic control in diabetics |
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Date of first enrolment:
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09/01/2005 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12605000260628.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Michelle Robbins
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Address:
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c/- Cardiovascular and Periodontal Study
Team Leader - Diabetes
Logan Hospital
Cnr Loganlea & Armstrong Rds
Meadowbrook QLD 4131
Australia |
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Telephone:
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+61 7 32999502 |
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Email:
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m.cullinan@uq.edu.au |
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Affiliation:
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Name:
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Dr Bill Westerman
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Address:
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Level 1 Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032
Australia |
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Telephone:
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+61 7 33508300 |
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Email:
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m.cullinan@uq.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: HbA1c>6%, Able to give informed consent, Minimum of 12 teeth, Chronic periodontitis.
Exclusion criteria: Pregnancy, Gross dental caries, Requirement of antibiotic cover for dental treatment, Anticoagulant therapy, other serious illness.
Age minimum:
35 Years
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Metabolic and Endocrine - Diabetes
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Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Diabetes and Periodontal Disease;
Diabetes and Periodontal Disease
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Intervention(s)
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Group1- periodontal treatment + random allocation to triclosan or non triclosan toothpaste. The response to treatment will be assessed at 2 weeks, 6 and 12 months.
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Primary Outcome(s)
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HbA1c[Measured at 6 and 12 months after treatment]
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C-peptide[Measured at 6 and 12 months after treatment]
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Secondary Outcome(s)
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Response to periodontal treatment + any added benefit from triclosan toothpaste[Assessed at 2 wks, 6 & 12 months. ]
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Inflammatory markers, plaque bacteria & antibodies also assessed.[]
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Source(s) of Monetary Support
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Colgate Palmolive Co
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Australian Dental Research Fund
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Ethics review
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Status: Not approved
Approval date:
Contact:
The Princess Alexandra Hospital Research Ethics Committee
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Status: Not approved
Approval date:
Contact:
The University of Queensland Medical Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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