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Periodontal Disease and Cardiovascular Disease

Primary Purpose

Periodontal Diseases

Status
Unknown status
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Triclosan
Fluoride
Fluoride
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Discipline of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Periodontal disease

Secondary Outcome Measures

Full Information

First Posted
September 26, 2008
Last Updated
September 30, 2008
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT00763165
Brief Title
Periodontal Disease and Cardiovascular Disease
Official Title
Periodontal Disease and Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2000 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Colgate Palmolive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Triclosan
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
Title
Periodontal disease
Time Frame
3-5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Seymour, BDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Discipline of Medicine
City
Chermside
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Periodontal Disease and Cardiovascular Disease

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