Periodontal Disease and Cardiovascular Disease

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00763165
• Collaborator: (none)
• Enrollment: 438
• Location: 1
• Arms: 2
• Duration (Months): 109
• Patients Per Site Per Month: 4

Study Details

Study Description

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; Drug: Fluoride	Phase 3

Study Design

• Study Type: Interventional
• 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: Nov 1, 2000
• Anticipated Primary Completion Date: Dec 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Drug: Triclosan; Brush twice daily; Drug: Fluoride; Brush twice daily
Placebo Comparator: B	Drug: Fluoride; Brush twice daily

Outcome Measures

Primary Outcome Measures

1. Periodontal disease [3-5 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Discipline of Medicine	Chermside		Australia

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Gregory Seymour, BDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00763165
• Other Study ID Numbers: D/06/Dent/99
• First Posted: Sep 30, 2008
• Last Update Posted: Oct 2, 2008
• Last Verified: Sep 1, 2008

• Additional relevant MeSH terms: Periodontal Diseases; Cardiovascular Diseases; Triclosan; Fluorides

Study Results

No Results Posted as of Oct 2, 2008