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OpenTrials
Completed

NCT Number: NCT00762853

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

The objective is to develop a method to determine active ingredient uptake in oral care products.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mahidol University

Bangkok, Bangkok 10110, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fluoride

Drug

Brush half mouth once with assigned study treatment

Fluoride and triclosan

Drug

Brush half mouth once with assigned study treatment

Other names: Colgate Total toothpaste

Primary outcomes

  1. Triclosan Concentration in Dental Plaque

    Time frame: 12 hours

    Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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