Clinical Study to Compare Dental Plaque Control

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758394
First received: September 23, 2008
Last updated: August 8, 2013
Last verified: August 2013

September 23, 2008
August 8, 2013
September 2007
November 2007   (final data collection date for primary outcome measure)
Dental Plaque Index [ Time Frame: 4-Day ] [ Designated as safety issue: No ]
plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.
Control established plaque in adults [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00758394 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Study to Compare Dental Plaque Control
Clinical Study to Compare Dental Plaque Control

This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

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 two times a day for 4 days.
    Other Name: monofluorophosphate
  • Drug: Triclosan/Fluoride
    Brush two times daily for 4 days
    Other Names:
    • sodium fluoride
    • triclosan
  • Drug: Triclosan/Fluoride
    Brush twice daily for 4 days
    Other Names:
    • sodium fluoride
    • triclosan
    • amino acid
  • Drug: Triclosan/Fluoride
    Brush twice daily for 4 days
    Other Names:
    • sodium fluoride
    • triclosan
    • amino acid/bicarbonate
  • Placebo Comparator: Fluoride - A
    Fluoride only toothpaste
    Intervention: Drug: Fluoride
  • Active Comparator: Total + Whitening toothpaste - B
    Triclosan/fluoride toothpaste
    Intervention: Drug: Triclosan/Fluoride
  • Experimental: Triclosan/fluoride/Amino Acid - C
    toothpaste containing amino acid #1
    Intervention: Drug: Triclosan/Fluoride
  • Experimental: Triclosan/fluoride/Cavistat -D
    toothpaste containing amino acid/bicarbonate
    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
29
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female volunteers at least 18 - 53 years of age
  • Good general health
  • Must sign informed consent form
  • 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 are currently affecting salivary function
  • 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 which interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • History of allergy to arginine (amino acid)
  • History of allergy to bicarbonate
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Both
18 Years to 53 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00758394
CRO-0907-PLA-14-RR
No
William DeVizio/VP - Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Patricia Corby, DDS
Colgate Palmolive
August 2013

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