Working… Menu
Trial record 5 of 43 for:    FLUORIDE ION AND TRICLOSAN

Efficacy of Salivary Bacteria and Post Brushing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00981825
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : September 22, 2009
Last Update Posted : June 14, 2011
Information provided by:
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Salivary Bacteria Levels Drug: Fluoride Drug: Triclosan/Fluoride Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Salivary Bacteria and Post Brushing
Study Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: A
fluoride toothpaste control
Drug: Fluoride
Whole mouth brushing for 7 days
Other Name: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)

Active Comparator: B
triclosan/fluoride toothpaste
Drug: Triclosan/Fluoride
Brush whole mouth twice daily for 7 days
Other Name: triclosan/fluoride toothpaste (Colgate Total toothpaste)

Primary Outcome Measures :
  1. CFU (Colony Forming Units) [ Time Frame: 4 hours ]
    Total number of salivary bacterial colony forming units (lower number = less colonies present)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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)

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 identifier (NCT number): NCT00981825

Layout table for location information
India GTC, Colgate Palmolive(I) ltd
Mumbai, India
Sponsors and Collaborators
Colgate Palmolive
Layout table for investigator information
Principal Investigator: Neelim Utgikar, DDS
Layout table for additonal information
Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive Identifier: NCT00981825    
Other Study ID Numbers: ER0-2007-SAL-01-GX
First Posted: September 22, 2009    Key Record Dates
Results First Posted: September 22, 2009
Last Update Posted: June 14, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents