Status:
COMPLETED
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Lead Sponsor:
Colgate Palmolive
Conditions:
Gingival Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment
Eligibility Criteria
Inclusion
- Male or female volunteers 18-65 years of age.
- Good general health.
- Must sign informed consent form.
- Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- 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
- Medical condition which requires pre-medication prior to dental procedures/visits.
- Medical condition which precludes eating/drinking for 12 hrs.
- History of allergy to common dentifrice ingredients.
- Subjects unable or unwilling to sign the informed consent form.
- Moderate or advanced periodontal disease.
- Two 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 can currently affect salivary flow.
- Current use of antibiotics.
- 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 30 days 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.
- Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00966953
Start Date
October 1 2007
End Date
January 1 2008
Last Update
September 22 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eastman Dental Center - University of Rochester
Rochester, New York, United States, 14642-8315