Status:
COMPLETED
Clinical Study to Compare Dental Plaque Control
Lead Sponsor:
Colgate Palmolive
Conditions:
Dental Plaque
Eligibility:
All Genders
18-53 years
Phase:
PHASE3
Brief Summary
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.
Detailed Description
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.
Eligibility Criteria
Inclusion
- Male or female volunteers at least 18 - 53 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
- 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).
- 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 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 dentifrice ingredients.
- History of allergy to arginine (amino acid)
- History of allergy to bicarbonate
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00758394
Start Date
September 1 2007
End Date
November 1 2007
Last Update
August 15 2013
Active Locations (1)
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1
Bluestone Center for Clinical Research, NYU College of Dentistry
New York, New York, United States, 10016