Clinical Study to Evaluate Dental Plaque
This study has been completed.
Sponsor:
Colgate Palmolive
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758290
First received: September 23, 2008
Last updated: November 20, 2008
Last verified: November 2008
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Purpose
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
| Condition | Intervention | Phase |
|---|---|---|
|
Gingival Diseases |
Drug: Triclosan/Fluoride Drug: Fluoride/triclosan |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Clinical Study to Evaluate Dental Plaque |
Resource links provided by NLM:
Further study details as provided by Colgate Palmolive:
Primary Outcome Measures:
- Dental Plaque Index [ Time Frame: 4 Day ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: Triclosan/Fluoride
Brush twice daily for 3 weeks
|
| Experimental: B |
Drug: Fluoride/triclosan
Brush daily for 3 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years to 51 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female volunteers at least 20 - 51 years of age
- Good general health
- Must sign informed consent form
- Minimum of 15 natural uncrowned teeth (excluding third molars) must be present
- No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion Criteria:
- Subjects unable or unwilling to sign the informed consent form
- Medical condition which requires pre-medication prior to dental visits/procedures
- Moderate or advanced periodontal disease or heavy dental tartar (calculus)
- 5 or more decayed untreated dental sites at screening (cavities)
- Other disease of the hard or soft oral tissues.
- Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
- Use of medications that are currently affecting salivary function
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1
- Pregnant or nursing women
- Participation in any other clinical study within 1 week prior to enrollment into this study
- Use of tobacco products
- Subjects who must receive dental treatment during the study dates
- Current use of Antibiotics for any purpose
- Presence of an orthodontic appliance which interferes with plaque scoring
- History of allergy to common toothpaste ingredients
- History of allergy to arginine (amino acid)
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758290
Locations
| United States, New York | |
| Bluestone Center for Clinical Research, NYU College of Dentistry | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
Colgate Palmolive
Investigators
| Principal Investigator: | Patricia Corby, DDS |
More Information
No publications provided
| Responsible Party: | William DeVizio/VP- Clinical Research, Colgate Palmolive |
| ClinicalTrials.gov Identifier: | NCT00758290 History of Changes |
| Other Study ID Numbers: | CRO-2008-PLA-13-RR |
| Study First Received: | September 23, 2008 |
| Results First Received: | October 16, 2008 |
| Last Updated: | November 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dental Plaque Gingival Diseases Dental Deposits Tooth Diseases Stomatognathic Diseases Periodontal Diseases Mouth Diseases Fluorides Triclosan Hexachlorophene Cariostatic Agents |
Protective Agents Physiological Effects of Drugs Pharmacologic Actions Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013