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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Salivary Bacteria and Post Brushing

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • 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)


Enrollment: 22
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981825

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

No publications provided

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
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fluorides
Triclosan
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 17, 2014