Compare the Clinical Efficacy of Prototype Toothpastes.

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Gingival Diseases

Treatments: Drug: Herbal Ingredient and fluoride; Drug: Fluoride; Drug: Triclosan and fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761930

CRO-2007-GIN-04-RR

Details and patient eligibility

About

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Enrollment: 103 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 16 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.
• Dental Selection Criteria: Average full mouth GI score should be in the range of
• • 2.0. heavy plaque formers should be avoided. Target a full mouth PI
• (Quigley-Hein) to be in the range of 1.5-3.0
• If of child bearing potential and on birth control (diaphragm, birth control pills,
• Birth control implants, IUD (Intrauterine device), condoms)

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
• 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 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.
• History of allergy to common dentifrice ingredients
• Presence of an orthodontic appliance which interferes with plaque scoring.
• History of allergy to natural remedies, such as herbal ingredients
• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
• Smoker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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103 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Description:

commercially available Fluoride toothpaste

Treatment:

Drug: Fluoride

B

Active Comparator group

Description:

fluoride/triclosan/copolymer toothpaste

Treatment:

Drug: Triclosan and fluoride

C

Experimental group

Description:

fluoride/herbal toothpaste

Treatment:

Drug: Herbal Ingredient and fluoride