Compare the Clinical Efficacy of Prototype Toothpastes.
Primary Purpose
Gingival Diseases
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan and fluoride
Herbal Ingredient and fluoride
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
- Minimum of 16 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.
- Dental Selection Criteria: Average full mouth GI score should be in the range of
- - 2.0. heavy plaque formers should be avoided. Target a full mouth PI
- (Quigley-Hein) to be in the range of 1.5-3.0
- If of child bearing potential and on birth control (diaphragm, birth control pills,
- Birth control implants, IUD (Intrauterine device), condoms)
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
- 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 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.
- History of allergy to common dentifrice ingredients
- Presence of an orthodontic appliance which interferes with plaque scoring.
- History of allergy to natural remedies, such as herbal ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Smoker
Sites / Locations
- Eastman Dental Center - University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
A
B
C
Arm Description
commercially available Fluoride toothpaste
fluoride/triclosan/copolymer toothpaste
fluoride/herbal toothpaste
Outcomes
Primary Outcome Measures
Dental Plaque
Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
Gingivitis Score
Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.
Bleeding Index (EIBI)
Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00761930
Brief Title
Compare the Clinical Efficacy of Prototype Toothpastes.
Official Title
Compare the Clinical Efficacy of Prototype Toothpastes.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
commercially available Fluoride toothpaste
Arm Title
B
Arm Type
Active Comparator
Arm Description
fluoride/triclosan/copolymer toothpaste
Arm Title
C
Arm Type
Experimental
Arm Description
fluoride/herbal toothpaste
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
Colgate Great Regular Flavor toothpaste
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Triclosan and fluoride
Other Intervention Name(s)
Colgate Total toothpaste
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Herbal Ingredient and fluoride
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
Title
Dental Plaque
Description
Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
Time Frame
6 weeks
Title
Gingivitis Score
Description
Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.
Time Frame
6 weeks
Title
Bleeding Index (EIBI)
Description
Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.
Time Frame
6 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
Minimum of 16 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.
Dental Selection Criteria: Average full mouth GI score should be in the range of
- 2.0. heavy plaque formers should be avoided. Target a full mouth PI
(Quigley-Hein) to be in the range of 1.5-3.0
If of child bearing potential and on birth control (diaphragm, birth control pills,
Birth control implants, IUD (Intrauterine device), condoms)
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
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 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.
History of allergy to common dentifrice ingredients
Presence of an orthodontic appliance which interferes with plaque scoring.
History of allergy to natural remedies, such as herbal ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Smoker
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
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Compare the Clinical Efficacy of Prototype Toothpastes.
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