Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000593639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
5/10/2005
Date last updated
5/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiovascular and Periodontal Study: a randomised controlled trial
Scientific title
The effect of a triclosan containing dentifrice on the relationship between periodontal disease and cardiovascular disease
Universal Trial Number (UTN)
Trial acronym
CAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontal disease 720 0
Cardiovascular disease 721 0
Condition category
Condition code
Cardiovascular 797 797 0 0
Other cardiovascular diseases
Oral and Gastrointestinal 798 798 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 552 0
None
Comparator / control treatment
Those in the control group will receive toothbrushing instruction at baseline and a placebo toothpaste.
Control group
Placebo

Outcomes
Primary outcome [1] 1020 0
Progression of periodontal disease in the triclosan versus placebo groups
Timepoint [1] 1020 0
Measured annually
Secondary outcome [1] 1912 0
Changes in serum lipid profiles
Timepoint [1] 1912 0
Measured at yearly intervals.
Secondary outcome [2] 1913 0
Inflammatory markers
Timepoint [2] 1913 0
Measured at yearly intervals.
Secondary outcome [3] 1914 0
Anti-HSP 60 and anti Pg-GroEL antibodies and periodontal bacteria
Timepoint [3] 1914 0
Measured at yearly intervals.
Secondary outcome [4] 1915 0
To determine if the primary outcome is influenced by genotype.
Timepoint [4] 1915 0

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Assignment to group by a dental assistant, after consent obtained, based on consecutive ID numbers. Toothpaste was packaged in identical tubes with code held by Colgate Australia until completion of data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation with subjects allocated to equal sized treatment groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 886 0
Commercial sector/Industry
Name [1] 886 0
Colgate Palmolive Co USA
Country [1] 886 0
United States of America
Primary sponsor type
University
Name
Oral Care Research Programme, The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 748 0
University
Name [1] 748 0
Malcolm West, Department of Medicine, The University of Queensland
Address [1] 748 0
Country [1] 748 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2171 0
The University of Queensland Dental Research Ethics Committee
Ethics committee address [1] 2171 0
Ethics committee country [1] 2171 0
Australia
Date submitted for ethics approval [1] 2171 0
Approval date [1] 2171 0
Ethics approval number [1] 2171 0
Ethics committee name [2] 2172 0
The Prince Charles Hospital Research Ethics Committee
Ethics committee address [2] 2172 0
Ethics committee country [2] 2172 0
Australia
Date submitted for ethics approval [2] 2172 0
Approval date [2] 2172 0
Ethics approval number [2] 2172 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36185 0
Address 36185 0
Country 36185 0
Phone 36185 0
Fax 36185 0
Email 36185 0
Contact person for public queries
Name 9741 0
Ms Anne Carle
Address 9741 0
Research Nurse
The Prince Charles Hospital
Level 1
Clinical Sciences Building
Rode Rd
Chermside QLD 4032
Country 9741 0
Australia
Phone 9741 0
+61 7 33508300
Fax 9741 0
Email 9741 0
carle@medicine.herston.uq.edu.au
Contact person for scientific queries
Name 669 0
Dr Mary Cullinan
Address 669 0
Oral Care Research Programme
Oral Biology and Pathology
The University of Queensland
Brisbane QLD 4072
Country 669 0
Australia
Phone 669 0
+61 7 33651905
Fax 669 0
+61 7 33651109
Email 669 0
m.cullinan@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.