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Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01024738
First received: September 26, 2008
Last updated: November 27, 2009
Last verified: October 2009

September 26, 2008
November 27, 2009
March 2008
April 2008   (final data collection date for primary outcome measure)
Plaque Index [ Time Frame: 4 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01024738 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

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 half mouth twice daily for four days.
  • Drug: Triclosan, fluoride
    Brush twice daily
    Other Name: Total toothpaste
  • Drug: Chlorhexidine Gluconate
    Rinse mouth twice a day
  • Placebo Comparator: Fluoride toothpaste
    negative control toothpaste
    Intervention: Drug: Fluoride
  • Active Comparator: Triclosan/Fluoride toothpaste
    positive control toothpaste (Total toothpaste)
    Intervention: Drug: Triclosan, fluoride
  • Active Comparator: Chlorhexidine Oral Rinse
    positive control oral rinse
    Intervention: Drug: Chlorhexidine Gluconate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be aged 18 to 65 years inclusive
  • Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
  • Give written informed consent
  • Be in good general health
  • No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
  • If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

  • Medical condition which requires pre-medication (antibiotics) prior to dental
  • Visits/procedures
  • Allergy to chlorhexidine
  • Advanced periodontal disease (gum disease)
  • 5 or more decayed, untreated dental sites (cavities)
  • Diseases of the soft or hard oral tissues (gums or palate)
  • Orthodontic appliances that interfere with plaque rating
  • Abnormal salivary function
  • Use of drugs that can affect currently salivary flow or production
  • 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)
  • Pregnant or breastfeeding.
  • Participation in another research study in the month preceding this study
  • Allergic to common toothpaste or mouth rinse ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01024738
CRO-2008-PLA-05-RR
No
William DeVizio/VP, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Mark LeFelt, DDS
Colgate Palmolive
October 2009

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