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Clinical Study to Compare Dental Plaque Control

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan/Fluoride
Triclosan/Fluoride
Triclosan/Fluoride
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Plaque

Eligibility Criteria

18 Years - 53 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Bluestone Center for Clinical Research, NYU College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

Fluoride - A

Total + Whitening toothpaste - B

Triclosan/fluoride/Amino Acid - C

Triclosan/fluoride/Cavistat -D

Arm Description

Fluoride only toothpaste

Triclosan/fluoride toothpaste

toothpaste containing amino acid #1

toothpaste containing amino acid/bicarbonate

Outcomes

Primary Outcome Measures

Dental Plaque Index
plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2008
Last Updated
August 8, 2013
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT00758394
Brief Title
Clinical Study to Compare Dental Plaque Control
Official Title
Clinical Study to Compare Dental Plaque Control
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Colgate Palmolive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.
Detailed Description
Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoride - A
Arm Type
Placebo Comparator
Arm Description
Fluoride only toothpaste
Arm Title
Total + Whitening toothpaste - B
Arm Type
Active Comparator
Arm Description
Triclosan/fluoride toothpaste
Arm Title
Triclosan/fluoride/Amino Acid - C
Arm Type
Experimental
Arm Description
toothpaste containing amino acid #1
Arm Title
Triclosan/fluoride/Cavistat -D
Arm Type
Experimental
Arm Description
toothpaste containing amino acid/bicarbonate
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
monofluorophosphate
Intervention Description
Brush two times a day for 4 days.
Intervention Type
Drug
Intervention Name(s)
Triclosan/Fluoride
Other Intervention Name(s)
sodium fluoride, triclosan
Intervention Description
Brush two times daily for 4 days
Intervention Type
Drug
Intervention Name(s)
Triclosan/Fluoride
Other Intervention Name(s)
sodium fluoride, triclosan, amino acid
Intervention Description
Brush twice daily for 4 days
Intervention Type
Drug
Intervention Name(s)
Triclosan/Fluoride
Other Intervention Name(s)
sodium fluoride, triclosan, amino acid/bicarbonate
Intervention Description
Brush twice daily for 4 days
Primary Outcome Measure Information:
Title
Dental Plaque Index
Description
plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.
Time Frame
4-Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Corby, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bluestone Center for Clinical Research, NYU College of Dentistry
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Clinical Study to Compare Dental Plaque Control

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