Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
This study has been completed.
Sponsor:
Colgate Palmolive
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00966953
First received: September 26, 2008
Last updated: September 14, 2009
Last verified: September 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment
| Condition | Intervention | Phase |
|---|---|---|
|
Gingival Diseases |
Drug: Fluoride Drug: Triclosan/Fluoride toothpaste Other: antibacterial plant extract |
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: | Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing. |
Resource links provided by NLM:
Further study details as provided by Colgate Palmolive:
Primary Outcome Measures:
- Plaque Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | October 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Fluoride Toothpaste
fluoride control
|
Drug: Fluoride
Brush twice daily
|
|
Active Comparator: Total/Whitening
positive control
|
Drug: Triclosan/Fluoride toothpaste
Brush twice daily
|
|
Experimental: antibacterial plant extract 1
Honokiol
|
Drug: Fluoride
Brush twice daily
Other Name: honokiol
|
|
Experimental: antibacterial plant extract 2
magnolol
|
Drug: Fluoride
Brush twice daily
Other: antibacterial plant extract
Brush twice daily
Other Name: Honokiol
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female volunteers 18-65 years of age.
- Good general health.
- Must sign informed consent form.
- Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- 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:
- Medical condition which requires pre-medication prior to dental procedures/visits.
- Medical condition which precludes eating/drinking for 12 hrs.
- History of allergy to common dentifrice ingredients.
- Subjects unable or unwilling to sign the informed consent form.
- Moderate or advanced periodontal disease.
- Two or more decayed untreated dental sites at screening.
- 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 can currently affect salivary flow.
- Current use of antibiotics.
- 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 30 days 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.
- Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966953
Locations
| United States, New York | |
| Eastman Dental Center - University of Rochester | |
| Rochester, New York, United States, 14642-8315 | |
Sponsors and Collaborators
Colgate Palmolive
Investigators
| Principal Investigator: | Yanfang Ren, DDS |
More Information
No publications provided
| Responsible Party: | William DeVizio/VP - Clinical Research, Colgate Palmolive |
| ClinicalTrials.gov Identifier: | NCT00966953 History of Changes |
| Other Study ID Numbers: | ERO-0907-PLA-16-RR |
| Study First Received: | September 26, 2008 |
| Results First Received: | September 26, 2008 |
| Last Updated: | September 14, 2009 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Gingival Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases Anti-Bacterial Agents Fluorides Triclosan Hexachlorophene Honokiol Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Cariostatic Agents Protective Agents Physiological Effects of Drugs |
Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Local Lipid Regulating Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Anti-Arrhythmia Agents Cardiovascular Agents Central Nervous System Depressants Central Nervous System Agents Enzyme Inhibitors Gastrointestinal Agents Anti-Anxiety Agents |
ClinicalTrials.gov processed this record on May 19, 2013