Status:
COMPLETED
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Lead Sponsor:
Colgate Palmolive
Conditions:
Dental Plaque
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The objective is to develop a method to determine active ingredient uptake in oral care products.
Eligibility Criteria
Inclusion
- Male or female volunteer 18 - 65 years of age (inclusive).
- Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)
- Able and willing to sign the informed consent form.
- Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.
- No known 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 not eating/drinking for 2 hours
- Advanced periodontal disease (gum disease)
- 5 or more decayed, untreated dental sites (cavities)
- Diseases of the soft or hard oral tissues
- Orthodontic appliances
- Abnormal salivary function
- Use of drugs that can affect salivary flow
- Use of antibiotics one (1) month prior to or during this study
- Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn, etc)
- Pregnant or breastfeeding.
- Participation in another clinical study in the month preceding this study
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00762853
Start Date
May 1 2008
End Date
June 1 2008
Last Update
February 17 2012
Active Locations (1)
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1
Mahidol University
Bangkok, Bangkok 10110, Thailand