Back to resultsClinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
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
- 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: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0
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
- History of allergy to iodine
- History of thyroid disease
- History of diabetes
- 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.
- Presence of an orthodontic appliance.
- History of allergy to common dentifrice ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
- Smoker
Sites / Locations
- University of Louisville, School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A
B
Arm Description
commercially available Fluoride only toothpaste
Commercially available triclosan/copolymer/fluoride toothpaste
Outcomes
Primary Outcome Measures
Control Established Plaque in Adults
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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.
Secondary Outcome Measures
Control Gingivitis in Adults
Gingivitis Index (GI) is described as 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 score = Sum of all scores divided by the number of sites (teeth scored).
Full Information
NCT ID
NCT00762515
First Posted
September 26, 2008
Last Updated
December 14, 2010
Sponsor
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT00762515
Brief Title
Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Official Title
Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to compare two commerical oral products for the treatment of gingivitis.
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
commercially available Fluoride only toothpaste
Arm Title
B
Arm Type
Active Comparator
Arm Description
Commercially available triclosan/copolymer/fluoride toothpaste
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush teeth two times daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Triclosan
Intervention Description
Brush two times daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush two times daily for 6 weeks
Primary Outcome Measure Information:
Title
Control Established Plaque in Adults
Description
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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Control Gingivitis in Adults
Description
Gingivitis Index (GI) is described as 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 score = Sum of all scores divided by the number of sites (teeth scored).
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: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0
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
History of allergy to iodine
History of thyroid disease
History of diabetes
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.
Presence of an orthodontic appliance.
History of allergy to common dentifrice ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
Smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Kinane, BDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville, School of Dentistry
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
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