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Efficacy of Salivary Bacteria and Post Brushing

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ClinicalTrials.gov Identifier: NCT00981825
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : September 22, 2009
Last Update Posted : June 14, 2011
Sponsor:
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

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

U.S. FDA Resources

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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00981825


Locations
India
India GTC, Colgate Palmolive(I) ltd
Mumbai, India
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Neelim Utgikar, DDS

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00981825     History of Changes
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:
Fluorides
Sodium Fluoride
Triclosan
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents