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Phase 3 N=20 Randomized Double-blind Treatment

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

Dental Plaque

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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