Evaluating Commercial Anti-Plaque Products and Oral Rinse

Colgate Palmolive1 site in 1 country26 target enrollmentAugust 2007

ConditionsDental Plaque

InterventionsFluoride Fluoride, triclosan Chlorhexidine digluconate

DrugsFluoride Chlorhexidine digluconate Fluoride, triclosan

Overview

Phase: Phase 2
Intervention: Fluoride
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Enrollment: 26
Locations: 1
Primary Endpoint: Plaque Index
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Detailed Description

This clinical research study was to train new examiners for short term plaque clinical methodologies.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

September 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Colgate Palmolive

Eligibility Criteria

Inclusion Criteria

•Male or female volunteers at least 18 years of age.
•Good general health.
•Must sign informed consent form.
•Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
•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

•Subjects unable or unwilling to sign the informed consent form.
•Medical condition which requires pre-medication prior to dental visits/procedures.
•Moderate or advanced periodontal disease or heavy dental tartar (calculus).
•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 are currently affect salivary function.
•Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #
•Allergy to chlorhexidine.
•Pregnant or nursing women.

Arms & Interventions

Fluoride toothpaste

Negative control

Intervention: Fluoride

Triclosan/Fluoride toothpaste

positive control toothpaste

Intervention: Fluoride, triclosan

Chlorhexidine Oral Rinse

Positive Control mouthrinse

Intervention: Chlorhexidine digluconate

Outcomes

Primary Outcomes

Plaque Index

Time Frame: Four days

Plaque 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)