Status:
COMPLETED
Efficacy of Salivary Bacteria and Post Brushing
Lead Sponsor:
Colgate Palmolive
Conditions:
Salivary Bacteria Levels
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
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.
- 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 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 :
December 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00981825
Start Date
October 1 2007
End Date
December 1 2007
Last Update
June 14 2011
Active Locations (1)
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1
India GTC, Colgate Palmolive(I) ltd
Mumbai, India