Clinical Study to Compare Dental Plaque Control

Phase 3

Completed

• Conditions: Dental Plaque
• Interventions: Drug: Fluoride; Drug: Triclosan/Fluoride

• Registration Number: NCT00758394
• Lead Sponsor: Colgate Palmolive

Brief Summary

This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Detailed Description

Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Results First Submitted: 2008-10-16
• Results First Submitted QC: 2008-11-18
• Results First Posted: 2008-11-19
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Male or female volunteers at least 18 - 53 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).
• 2 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 affecting salivary function
• 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 1 week 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.
• Presence of an orthodontic appliance which interferes with plaque scoring.
• History of allergy to common dentifrice ingredients.
• History of allergy to arginine (amino acid)
• History of allergy to bicarbonate
• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluoride - A	Fluoride	Fluoride only toothpaste
Total + Whitening toothpaste - B	Triclosan/Fluoride	Triclosan/fluoride toothpaste
Triclosan/fluoride/Amino Acid - C	Triclosan/Fluoride	toothpaste containing amino acid #1
Triclosan/fluoride/Cavistat -D	Triclosan/Fluoride	toothpaste containing amino acid/bicarbonate

Primary Outcome Measures

Name	Time	Method
Dental Plaque Index	4-Day	plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.

Trial Locations

Locations (1)

Bluestone Center for Clinical Research, NYU College of Dentistry; 🇺🇸 New York, New York, United States