Status:
COMPLETED
Compare the Clinical Efficacy of Prototype Toothpastes
Lead Sponsor:
Colgate Palmolive
Conditions:
Dental Plaque
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
Eligibility Criteria
Inclusion
- Male or female volunteers 18-65 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
- Subject 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.
- 5 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 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.
- History of allergy to zinc.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00926029
Start Date
January 1 2008
End Date
April 1 2008
Last Update
February 17 2012
Active Locations (1)
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1
Concordia Clinical Research
Cedar Knolls, New Jersey, United States, 07927