Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
| Sponsors |
Lead Sponsor: Colgate Palmolive |
|---|---|
| Source | Colgate Palmolive |
| Brief Summary | Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment |
| Overall Status | Completed | ||||
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| Start Date | 2007-10-01 | ||||
| Completion Date | 2008-01-01 | ||||
| Primary Completion Date | 2008-01-01 | ||||
| Phase | Phase 3 | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Enrollment | 25 |
| Condition | |
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| Intervention |
Intervention Type: Drug Intervention Name: Fluoride Description: Brush twice daily Arm Group Label: Fluoride Toothpaste Intervention Type: Drug Intervention Name: Triclosan/Fluoride toothpaste Description: Brush twice daily Arm Group Label: Total/Whitening Intervention Type: Drug Intervention Name: Fluoride Description: Brush twice daily Arm Group Label: antibacterial plant extract 1 Other Name: honokiol Intervention Type: Drug Intervention Name: Fluoride Description: Brush twice daily Arm Group Label: antibacterial plant extract 2 Intervention Type: Other Intervention Name: antibacterial plant extract Description: Brush twice daily Arm Group Label: antibacterial plant extract 2 Other Name: Honokiol |
| Eligibility |
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). Gender: All Minimum Age: 18 Years Maximum Age: 65 Years Healthy Volunteers: Accepts Healthy Volunteers |
| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
2009-09-01 |
| Responsible Party |
Name Title: William DeVizio/VP - Clinical Research Organization: Colgate Palmolive |
| Has Expanded Access | No |
| Condition Browse | |
| Number Of Arms | 4 |
| Arm Group |
Label: Fluoride Toothpaste Type: Placebo Comparator Description: fluoride control Label: Total/Whitening Type: Active Comparator Description: positive control Label: antibacterial plant extract 1 Type: Experimental Description: Honokiol Label: antibacterial plant extract 2 Type: Experimental Description: magnolol |
| Study Design Info |
Allocation: Randomized Intervention Model: Crossover Assignment Primary Purpose: Treatment Masking: Double (Participant, Investigator) |
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