Clinical Study to Compare Dental Plaque Control

August 8, 2013 updated by: Colgate Palmolive
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10016
        • Bluestone Center for Clinical Research, NYU College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 53 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Fluoride - A
Fluoride only toothpaste
Brush two times a day for 4 days.
Other Names:
  • monofluorophosphate
Active Comparator: Total + Whitening toothpaste - B
Triclosan/fluoride toothpaste
Brush two times daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
Brush twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
  • amino acid/bicarbonate
Experimental: Triclosan/fluoride/Amino Acid - C
toothpaste containing amino acid #1
Brush two times daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
Brush twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
  • amino acid/bicarbonate
Experimental: Triclosan/fluoride/Cavistat -D
toothpaste containing amino acid/bicarbonate
Brush two times daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
Brush twice daily for 4 days
Other Names:
  • sodium fluoride
  • triclosan
  • amino acid/bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Plaque Index
Time Frame: 4-Day
plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.
4-Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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