Train New Examiners Via Modified Gingival Margin Plaque
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan/Fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque
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 for 24-hrs.after initial appointment.
- 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 can affect salivary flow
- 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.
- History of allergy to common dentifrice ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Sites / Locations
- Northampton Community College
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Mean Gingival Plaque Units
Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).
Secondary Outcome Measures
Full Information
NCT ID
NCT00758563
First Posted
September 23, 2008
Last Updated
November 20, 2008
Sponsor
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT00758563
Brief Title
Train New Examiners Via Modified Gingival Margin Plaque
Official Title
Train New Examiners Via Modified Gingival Margin Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.
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
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Triclosan/Fluoride
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
Title
Mean Gingival Plaque Units
Description
Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).
Time Frame
1 day
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 for 24-hrs.after initial appointment.
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 can affect salivary flow
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.
History of allergy to common dentifrice ingredients.
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Sigal-Greene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northampton Community College
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
12. IPD Sharing Statement
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Train New Examiners Via Modified Gingival Margin Plaque
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