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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: |
ACTRN12605000593639 |
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Date of registration:
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05/10/2005 |
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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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Cardiovascular and Periodontal Study: a randomised controlled trial
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Scientific title:
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The effect of a triclosan containing dentifrice on the relationship between periodontal disease and cardiovascular disease |
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Date of first enrolment:
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01/01/2000 |
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Target sample size:
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500 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://anzctr.org.au/ACTRN12605000593639.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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Dr Mary Cullinan
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Address:
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Oral Care Research Programme
Oral Biology and Pathology
The University of Queensland
Brisbane QLD 4072
Australia |
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Telephone:
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+61 7 33651905 |
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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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Ms Anne Carle
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Address:
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Research Nurse
The Prince Charles Hospital
Level 1
Clinical Sciences Building
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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carle@medicine.herston.uq.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Ecidence of myocardial infarction within the previous 3 years, recent events within the previous 3 years - episodes of unstable angina, admission to hospital, abnormal cardiogram.
Exclusion criteria: No exclusion criteria
Age minimum:
Not stated
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cardiovascular - Other cardiovascular diseases
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Periodontal disease;Cardiovascular disease;
Periodontal disease
Cardiovascular disease
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Intervention(s)
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Patients in the intervention arm will be given toothbrushing instruction at baseline and provided with a triclosan toothpaste. Both groups will be enrolled for 3-5 years and examined annually.
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Primary Outcome(s)
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Progression of periodontal disease in the triclosan versus placebo groups[Measured annually]
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Secondary Outcome(s)
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Inflammatory markers[Measured at yearly intervals.]
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To determine if the primary outcome is influenced by genotype.
[]
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Anti-HSP 60 and anti Pg-GroEL antibodies and periodontal bacteria[Measured at yearly intervals.]
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Changes in serum lipid profiles[Measured at yearly intervals.]
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Source(s) of Monetary Support
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Colgate Palmolive Co USA
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Ethics review
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Status: Not approved
Approval date:
Contact:
The Prince Charles Hospital Research Ethics Committee
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Status: Not approved
Approval date:
Contact:
The University of Queensland Dental 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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