Back to resultsClinical Study to Evaluate Dental Plaque
Primary Purpose
Gingival Diseases
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Triclosan/Fluoride
Fluoride/triclosan
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Diseases
Eligibility Criteria
Inclusion Criteria:
- Male or female volunteers at least 20 - 51 years of age
- Good general health
- Must sign informed consent form
- Minimum of 15 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)
- 5 or more decayed untreated dental sites at screening (cavities)
- 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 toothpaste ingredients
- History of allergy to arginine (amino acid)
- 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 Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Dental Plaque Index
Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
Secondary Outcome Measures
Full Information
NCT ID
NCT00758290
First Posted
September 23, 2008
Last Updated
November 20, 2008
Sponsor
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT00758290
Brief Title
Clinical Study to Evaluate Dental Plaque
Official Title
Clinical Study to Evaluate Dental Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triclosan/Fluoride
Intervention Description
Brush twice daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Fluoride/triclosan
Intervention Description
Brush daily for 3 weeks
Primary Outcome Measure Information:
Title
Dental Plaque Index
Description
Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque
Time Frame
4 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female volunteers at least 20 - 51 years of age
Good general health
Must sign informed consent form
Minimum of 15 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)
5 or more decayed untreated dental sites at screening (cavities)
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 toothpaste ingredients
History of allergy to arginine (amino acid)
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
Learn more about this trial
Clinical Study to Evaluate Dental Plaque
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