Clinical Study to Evaluate Dental Plaque

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.

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

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Fluorides; Triclosan

Criteria

Inclusion Criteria:

• Male or female volunteers at least 20 - 51 years of age

• Good general health

• Must sign informed consent form

• Minimum of 15 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)

• 5 or more decayed untreated dental sites at screening (cavities)

• 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 toothpaste ingredients

• History of allergy to arginine (amino acid)

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)