Compare the Clinical Efficacy of Prototype Toothpastes.

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Fluorides; Listerine; Sodium Fluoride; Triclosan

Criteria

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