Periodontal Disease and Cardiovascular Disease

This study is ongoing, but not recruiting participants.

First Received: September 26, 2008 Last Updated: September 30, 2008 History of Changes

Sponsor:	Colgate Palmolive
Information provided by:	Colgate Palmolive
ClinicalTrials.gov Identifier:	NCT00763165

Purpose

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

Condition	Intervention	Phase
Periodontal Diseases	Drug: Triclosan Drug: Fluoride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Periodontal Disease and Cardiovascular Disease

Resource links provided by NLM:

Drug Information available for: Hexachlorophene Fluoride Triclosan Sodium fluoride Stannous fluoride

U.S. FDA Resources

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:

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

Enrollment:	438
Study Start Date:	November 2000
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Triclosan Brush twice daily Drug: Fluoride Brush twice daily
B: Placebo Comparator	Drug: Fluoride Brush twice daily

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763165

Locations

Australia
Discipline of Medicine
Chermside, Australia

Sponsors and Collaborators

Colgate Palmolive

Investigators

Principal Investigator:

Gregory Seymour, BDS

Unaffiliated

More Information

No publications provided

Responsible Party:	Colgate Palmolive ( William DeVizio/VP - Clinical Research )
Study ID Numbers:	D/06/Dent/99
Study First Received:	September 26, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00763165 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Mouth Diseases
Antimetabolites
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Anti-Infective Agents, Local

Periodontal Diseases
Cariostatic Agents
Therapeutic Uses
Cardiovascular Diseases
Stomatognathic Diseases
Fluorides
Triclosan
Fatty Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2009