Clinical Study to Compare Dental Plaque Control

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758394
First received: September 23, 2008
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.


Condition Intervention Phase
Dental Plaque
Drug: Fluoride
Drug: Triclosan/Fluoride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Study to Compare Dental Plaque Control

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Dental Plaque Index [ Time Frame: 4-Day ] [ Designated as safety issue: No ]
    plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.


Enrollment: 29
Study Start Date: September 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fluoride - A
Fluoride only toothpaste
Drug: Fluoride
Brush two times a day for 4 days.
Other Name: monofluorophosphate
Active Comparator: Total + Whitening toothpaste - B
Triclosan/fluoride toothpaste
Drug: Triclosan/Fluoride
Brush two times daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
Experimental: Triclosan/fluoride/Amino Acid - C
toothpaste containing amino acid #1
Drug: Triclosan/Fluoride
Brush twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
  • amino acid
Experimental: Triclosan/fluoride/Cavistat -D
toothpaste containing amino acid/bicarbonate
Drug: Triclosan/Fluoride
Brush twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
  • amino acid/bicarbonate

Detailed Description:

Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

  Eligibility

Ages Eligible for Study:   18 Years to 53 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteers at least 18 - 53 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
  • 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:

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus).
  • 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 are currently affecting salivary function
  • 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 1 week 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.
  • Presence of an orthodontic appliance which interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • History of allergy to arginine (amino acid)
  • History of allergy to bicarbonate
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758394

Locations
United States, New York
Bluestone Center for Clinical Research, NYU College of Dentistry
New York, New York, United States, 10016
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Patricia Corby, DDS
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00758394     History of Changes
Other Study ID Numbers: CRO-0907-PLA-14-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Fluorophosphate
Listerine
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 April 17, 2014