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| Sponsored by: |
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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
Mouth Diseases Periodontal Diseases Hexachlorophene |
Stomatognathic Diseases Fluorides Triclosan |
|
Mouth Diseases Periodontal Diseases Cariostatic Agents Physiological Effects of Drugs Cardiovascular Diseases |
Stomatognathic Diseases Fluorides Protective Agents Pharmacologic Actions |