Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

NCT ID: NCT00966953

Last Updated: 2009-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-01-31

Brief Summary

Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment

Conditions

Gingival Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fluoride Toothpaste

fluoride control

Group Type: PLACEBO_COMPARATOR

Fluoride

Intervention Type: DRUG

Brush twice daily

Total/Whitening

positive control

Group Type: ACTIVE_COMPARATOR

Triclosan/Fluoride toothpaste

Intervention Type: DRUG

Brush twice daily

antibacterial plant extract 1

Honokiol

Group Type: EXPERIMENTAL

Fluoride

Intervention Type: DRUG

Brush twice daily

antibacterial plant extract 2

magnolol

Group Type: EXPERIMENTAL

Fluoride

Intervention Type: DRUG

Brush twice daily

antibacterial plant extract

Intervention Type: OTHER

Brush twice daily

Interventions

Fluoride

Brush twice daily

Intervention Type: DRUG

Triclosan/Fluoride toothpaste

Brush twice daily

Intervention Type: DRUG

Fluoride

Brush twice daily

Intervention Type: DRUG

Fluoride

Brush twice daily

Intervention Type: DRUG

antibacterial plant extract

Brush twice daily

Intervention Type: OTHER

Other Intervention Names

honokiol; 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Colgate Palmolive

Principal Investigators

Yanfang Ren, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

Eastman Dental Center - University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

ERO-0907-PLA-16-RR

Identifier Type: -

Identifier Source: org_study_id