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
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, see Learn About Clinical Studies.

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
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on August 28, 2014