Phase 3
N=20
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT00762853 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Triclosan Concentration in Dental Plaque — 0; 1.8 ppm levels of triclosan — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluoride (Drug); Fluoride and triclosan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Triclosan Concentration in Dental Plaque |
0; 1.8 | 0.05 |
Summary
The objective is to develop a method to determine active ingredient uptake in oral care products.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00762853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.