Clinical Study to Evaluate Dental Plaque

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Gingival Diseases

Treatments

Drug: Fluoride/triclosan

Drug: Triclosan/Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

CRO-2008-PLA-13-RR

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

All

Ages

20 to 51 years old

Volunteers

Accepts Healthy Volunteers

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)