Compare the Clinical Efficacy of Prototype Toothpastes

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque

Treatments: Drug: Triclosan, fluoride; Drug: Fluoride; Other: Metal salt

Study type: Interventional

Funder types: Industry

Identifiers

NCT00926029

CRO-2007-GIN-06-RR

Details and patient eligibility

About

Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female volunteers 18-65 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

• Subject 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.
• 5 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 currently affect salivary flow.
• 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.
• History of allergy to common dentifrice ingredients.
• History of allergy to zinc.
• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 3 patient groups, including a placebo group

Fluoride control -A

Placebo Comparator group

Description:

Winterfresh Gel

Treatment:

Drug: Fluoride

Triclosan/Fluoride - B

Active Comparator group

Description:

Positive control (Total toothpaste)

Treatment:

Drug: Triclosan, fluoride

Triclosan/fluoride/metal salt- C

Experimental group

Description:

test toothpaste

Treatment:

Other: Metal salt