Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Primary Purpose
Gingival Diseases
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan/Fluoride toothpaste
Fluoride
Fluoride
antibacterial plant extract
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Diseases
Eligibility 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.
- Two 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).
Sites / Locations
- Eastman Dental Center - University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Experimental
Experimental
Arm Label
Fluoride Toothpaste
Total/Whitening
antibacterial plant extract 1
antibacterial plant extract 2
Arm Description
fluoride control
positive control
Honokiol
magnolol
Outcomes
Primary Outcome Measures
Plaque Index
Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Secondary Outcome Measures
Full Information
NCT ID
NCT00966953
First Posted
September 26, 2008
Last Updated
September 14, 2009
Sponsor
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT00966953
Brief Title
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Official Title
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 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 the anti-plaque efficacy of prototype dentifrices via a 4-day 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
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride Toothpaste
Arm Type
Placebo Comparator
Arm Description
fluoride control
Arm Title
Total/Whitening
Arm Type
Active Comparator
Arm Description
positive control
Arm Title
antibacterial plant extract 1
Arm Type
Experimental
Arm Description
Honokiol
Arm Title
antibacterial plant extract 2
Arm Type
Experimental
Arm Description
magnolol
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Triclosan/Fluoride toothpaste
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
honokiol
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush twice daily
Intervention Type
Other
Intervention Name(s)
antibacterial plant extract
Other Intervention Name(s)
Honokiol
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
Title
Plaque Index
Description
Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Two 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanfang Ren, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastman Dental Center - University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-8315
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
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