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Train New Examiners Via Modified Gingival Margin Plaque

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758563
First received: September 23, 2008
Last updated: November 20, 2008
Last verified: November 2008

September 23, 2008
November 20, 2008
March 2008
April 2008   (final data collection date for primary outcome measure)
Mean Gingival Plaque Units [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Train new plaque examiners [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00758563 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Train New Examiners Via Modified Gingival Margin Plaque
Train New Examiners Via Modified Gingival Margin Plaque

The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dental Plaque
  • Drug: Fluoride
    Brush twice daily
  • Drug: Triclosan/Fluoride
    Brush twice daily
  • Placebo Comparator: A
    Intervention: Drug: Fluoride
  • Active Comparator: B
    Intervention: Drug: Triclosan/Fluoride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female volunteers 18-65 years of age
  • Good general health
  • Must sign informed consent form
  • Must discontinue oral hygiene for 24-hrs.after initial appointment.
  • Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
  • No 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:

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus).
  • 2 or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that can affect salivary flow
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week prior to enrollment into this study.
  • Use of tobacco products
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • Presence of an orthodontic appliance.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00758563
CRO-0907-PLA-18-RR
Yes
William DeVizio/VP - Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Terry Sigal-Greene
Colgate Palmolive
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP