Evaluating Commercial Anti-Plaque Products and Oral Rinse

Colgate-Palmolive

Status and phase: Completed; Phase 2

Conditions: Dental Plaque

Treatments: Drug: Fluoride; Drug: Chlorhexidine digluconate; Drug: Fluoride, triclosan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014143

CRO-2007-PLA-15-RR

Details and patient eligibility

About

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

Full description

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

Enrollment: 26 patients

Sex: All

Ages: 23 to 81 years old

Volunteers: Accepts Healthy Volunteers

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 #1.
• Allergy to chlorhexidine.
• 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 pre-medication for dental treatment or for any other purpose.
• Presence of an orthodontic appliance that interferes with plaque scoring.
• History of allergy to common dentifrice ingredients.
• 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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26 participants in 3 patient groups, including a placebo group

Fluoride toothpaste

Placebo Comparator group

Description:

Negative control

Treatment:

Drug: Fluoride

Triclosan/Fluoride toothpaste

Active Comparator group

Description:

positive control toothpaste

Treatment:

Drug: Fluoride, triclosan

Chlorhexidine Oral Rinse

Active Comparator group

Description:

Positive Control mouthrinse

Treatment:

Drug: Chlorhexidine digluconate