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

Phase 3

Completed

Interventions: Drug: Fluoride
Drug: Triclosan/Fluoride toothpaste
Other: antibacterial plant extract

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

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Fluoride Toothpaste	Fluoride	fluoride control
antibacterial plant extract 2	antibacterial plant extract	magnolol
antibacterial plant extract 1	Fluoride	Honokiol
Total/Whitening	Triclosan/Fluoride toothpaste	positive control
antibacterial plant extract 2	Fluoride	magnolol

Primary Outcome Measures

Name	Time	Method
Plaque Index	8 weeks	Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

Secondary Outcome Measures