Status:
COMPLETED
Compare the Clinical Efficacy of Prototype Toothpastes.
Lead Sponsor:
Colgate Palmolive
Conditions:
Gingival Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation
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: Average full mouth GI score should be in the range of
- \- 2.0. heavy plaque formers should be avoided. Target a full mouth PI
- (Quigley-Hein) to be in the range of 1.5-3.0
- If of child bearing potential and on birth control (diaphragm, birth control pills,
- Birth control implants, IUD (Intrauterine device), condoms)
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
- 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.
- History of allergy to common dentifrice ingredients
- Presence of an orthodontic appliance which interferes with plaque scoring.
- History of allergy to natural remedies, such as herbal ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Smoker
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00761930
Start Date
March 1 2008
End Date
June 1 2008
Last Update
August 15 2013
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