Status:
COMPLETED
Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Lead Sponsor:
Colgate Palmolive
Conditions:
Dental Plaque
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The objective is to compare two commerical oral products for the treatment of gingivitis.
Eligibility Criteria
Inclusion
- 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: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0
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
- History of allergy to iodine
- History of thyroid disease
- History of diabetes
- 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.
- Presence of an orthodontic appliance.
- History of allergy to common dentifrice ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
- Smoker
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00762515
Start Date
February 1 2008
End Date
August 1 2008
Last Update
December 28 2010
Active Locations (1)
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1
University of Louisville, School of Dentistry
Louisville, Kentucky, United States, 40292