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Periodontal Disease and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT00763165
Recruitment Status : Unknown
Verified September 2008 by Colgate Palmolive.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2008
Last Update Posted : October 2, 2008
Sponsor:
Information provided by:
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Periodontal Diseases Drug: Triclosan Drug: Fluoride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Periodontal Disease and Cardiovascular Disease
Study Start Date : November 2000
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: A Drug: Triclosan
Brush twice daily

Drug: Fluoride
Brush twice daily

Placebo Comparator: B Drug: Fluoride
Brush twice daily




Primary Outcome Measures :
  1. Periodontal disease [ Time Frame: 3-5 Years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763165


Locations
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Australia
Discipline of Medicine
Chermside, Australia
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Gregory Seymour, BDS

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Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00763165     History of Changes
Other Study ID Numbers: D/06/Dent/99
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 2, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Triclosan
Fluorides
Periodontal Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents