Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00763165




Registration number
NCT00763165
Ethics application status
Date submitted
26/09/2008
Date registered
30/09/2008
Date last updated
2/10/2008

Titles & IDs
Public title
Periodontal Disease and Cardiovascular Disease
Scientific title
Periodontal Disease and Cardiovascular Disease
Secondary ID [1] 0 0
D/06/Dent/99
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontal Diseases 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Triclosan
Treatment: Drugs - Fluoride
Treatment: Drugs - Fluoride

Active Comparator: A -

Placebo Comparator: B -


Treatment: Drugs: Triclosan
Brush twice daily

Treatment: Drugs: Fluoride
Brush twice daily

Treatment: Drugs: Fluoride
Brush twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Periodontal disease
Timepoint [1] 0 0
3-5 Years

Eligibility
Key inclusion criteria
- A minimum of 12 uncrowned teeth other than 3rd molars

- Age 18 to 75 years

- Informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Prosthetic heart valves

- Prosthetic joint replacement

- Previous infective endocarditis

- Requirement for antibiotic cover for dental treatment

- Current treatment with warfarin

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2009
Actual
Sample size
Target
Accrual to date
Final
438
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Discipline of Medicine - Chermside
Recruitment postcode(s) [1] 0 0
- Chermside

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Colgate Palmolive
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To access the influence of triclosan dentifrice on the progression of periodontal disease in
patients with coronary heart disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00763165
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Seymour, BDS
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00763165