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
Start Date 2007-10-01
Completion Date 2008-01-01
Primary Completion Date 2008-01-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Plaque Index 8 weeks
Enrollment 25
Condition
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
Last Name Role
Yanfang Ren, DDS Principal Investigator
Location
Facility: Eastman Dental Center - University of Rochester
Location Countries

United States

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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