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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00763165