Efficacy of Salivary Bacteria and Post Brushing

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00981825
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011

September 26, 2008
June 10, 2011
October 2007
December 2007   (final data collection date for primary outcome measure)
CFU (Colony Forming Units) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Total number of salivary bacterial colony forming units (lower number = less colonies present)
CFU (Colony Forming Units) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00981825 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Salivary Bacteria and Post Brushing
Efficacy of Salivary Bacteria and Post Brushing

Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Salivary Bacteria Levels
  • Drug: Fluoride
    Whole mouth brushing for 7 days
    Other Name: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
  • Drug: Triclosan/Fluoride
    Brush whole mouth twice daily for 7 days
    Other Name: triclosan/fluoride toothpaste (Colgate Total toothpaste)
  • Placebo Comparator: A
    fluoride toothpaste control
    Intervention: Drug: Fluoride
  • Active Comparator: B
    triclosan/fluoride toothpaste
    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
22
December 2007
December 2007   (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 on the mornings of each appointment and between sampling periods.
  • 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:

  • Medical condition which requires pre-medication prior to dental procedures/visits
  • Medical condition which precludes eating/drinking for 12 hrs.
  • History of allergy to common dentifrice ingredients
  • Subjects unable or unwilling to sign the informed consent form.
  • Moderate or advanced periodontal disease.
  • 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 currently affect salivary flow
  • Current use of antibiotics
  • 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 30 days 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.
  • 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
India
 
NCT00981825
ER0-2007-SAL-01-GX
No
William DeVizio/VP - Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Neelim Utgikar, DDS
Colgate Palmolive
June 2011

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