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Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

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ClinicalTrials.gov Identifier: NCT00762853
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : September 14, 2010
Last Update Posted : February 17, 2012
Sponsor:
Information provided by:
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Fluoride Drug: Fluoride and triclosan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
Study Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arm Intervention/treatment
Placebo Comparator: A
fluoride toothpaste from Thailand
Drug: Fluoride
Brush half mouth once with assigned study treatment

Active Comparator: B
fluoride/triclosan/copolymer toothpaste
Drug: Fluoride and triclosan
Brush half mouth once with assigned study treatment
Other Name: Colgate Total toothpaste




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762853


Locations
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Thailand
Mahidol University
Bangkok, Bangkok 10110, Thailand
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Terdphong Triantana, DDS

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Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762853     History of Changes
Other Study ID Numbers: CRO-2008-PLA-16-RR
First Posted: September 30, 2008    Key Record Dates
Results First Posted: September 14, 2010
Last Update Posted: February 17, 2012
Last Verified: August 2010
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Triclosan
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents