Periodontal Disease and Cardiovascular Disease | NCT00763165

Studies
Periodontal Disease and Cardiovascular Disease

NCT00763165

Sponsor

Colgate Palmolive

Status

Unknown status

Last Update Posted

Oct 2, 2008Estimated

Enrollment

438Actual

Phase

Phase 3

Conditions

Periodontal Diseases

Interventions

Triclosan
Fluoride
Fluoride

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2000

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Sep 26, 2008

First Submission Date that Met QC Criteria

Sep 26, 2008

First Posted Date

Sep 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2008

Last Update Posted Date

Oct 2, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

438Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Triclosan Drug: Fluoride
B	Placebo Comparator		Drug: Fluoride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triclosan	Drug	Brush twice daily	A
Fluoride

Measure	Description	Time Frame
Periodontal disease		3-5 Years

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Seymour, BDS		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Discipline of Medicine		Chermside			Australia

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014260	Triclosan
D005459	Fluorides

Ancestor Terms

ID	Term
D010647	Phenyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D010636	Phenols
D001555

Browse Leaves

Not provided

Browse Branches

Not provided