Periodontal Disease and Cardiovascular Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

September 26, 2008

Last Updated Date

September 30, 2008

Start Date ^ICMJE

November 2000

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Periodontal disease [ Time Frame: 3-5 Years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00763165 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Periodontal Disease and Cardiovascular Disease

Official Title ^ICMJE

Periodontal Disease and Cardiovascular Disease

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Periodontal Diseases

Intervention ^ICMJE

Drug: Triclosan
Drug: Fluoride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

438

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT ID ^ICMJE

NCT00763165

Responsible Party

William DeVizio/VP - Clinical Research, Colgate Palmolive

Study ID Numbers ^ICMJE

D/06/Dent/99

Study Sponsor ^ICMJE

Colgate Palmolive

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gregory Seymour, BDS

Unaffiliated

Information Provided By

Colgate Palmolive

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP