Clinical Study to Compare Dental Plaque Control

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque

Treatments: Drug: Fluoride; Drug: Triclosan/Fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758394

CRO-0907-PLA-14-RR

Details and patient eligibility

About

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

Full description

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

Enrollment: 29 patients

Sex: All

Ages: 18 to 53 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 4 patient groups, including a placebo group

Fluoride - A

Placebo Comparator group

Description:

Fluoride only toothpaste

Treatment:

Drug: Fluoride

Total + Whitening toothpaste - B

Active Comparator group

Description:

Triclosan/fluoride toothpaste

Treatment:

Drug: Triclosan/Fluoride

Drug: Triclosan/Fluoride

Drug: Triclosan/Fluoride

Triclosan/fluoride/Amino Acid - C

Experimental group

Description:

toothpaste containing amino acid #1

Treatment:

Drug: Triclosan/Fluoride

Drug: Triclosan/Fluoride

Drug: Triclosan/Fluoride

Triclosan/fluoride/Cavistat -D

Experimental group

Description:

toothpaste containing amino acid/bicarbonate

Treatment:

Drug: Triclosan/Fluoride

Drug: Triclosan/Fluoride

Drug: Triclosan/Fluoride