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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00763165
Other study ID # D/06/Dent/99
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received September 26, 2008
Last updated September 30, 2008
Start date November 2000
Est. completion date December 2009

Study information

Verified date September 2008
Source Colgate Palmolive
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 438
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- A minimum of 12 uncrowned teeth other than 3rd molars

- Age 18 to 75 years

- Informed consent

Exclusion Criteria:

- Prosthetic heart valves

- Prosthetic joint replacement

- Previous infective endocarditis

- Requirement for antibiotic cover for dental treatment

- Current treatment with warfarin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Triclosan
Brush twice daily
Fluoride
Brush twice daily
Fluoride
Brush twice daily

Locations

Country Name City State
Australia Discipline of Medicine Chermside

Sponsors (1)

Lead Sponsor Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Periodontal disease 3-5 Years No
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