Back to resultsComparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Triclosan, fluoride
Fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis and Plaque
Eligibility Criteria
Inclusion Criteria:
- Availability for the six-month duration of the study.
- Good general health.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
- Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
- Signed Informed Consent Form.
Exclusion Criteria:
- Presence of orthodontic bands.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of
- periodontal attachment or alveolar bone).
- Five or more carious lesions requiring immediate restorative treatment.
- Use of antibiotics any time during the one month prior to entry into the study.
- Participation in any other clinical study or test panel within the one month prior to entry
- into the study.
- Pregnant women or women who are breast feeding.
- Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
- History of allergic to personal care/consumer products or their ingredients.
- Taking any prescription medicines. That might interfere with the study outcome.
- Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.
Sites / Locations
- Dr. Fernando Autran
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A -Experimental toothpaste
B - control toothpaste
Arm Description
triclosan/copolymer/fluoride toothpaste
sodium fluoride only toothpaste (placebo)
Outcomes
Primary Outcome Measures
Gingivitis Index
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)
Plaque Index
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
1. Study Identification
Unique Protocol Identification Number
NCT00926328
Brief Title
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Official Title
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Gingivitis and Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A -Experimental toothpaste
Arm Type
Active Comparator
Arm Description
triclosan/copolymer/fluoride toothpaste
Arm Title
B - control toothpaste
Arm Type
Placebo Comparator
Arm Description
sodium fluoride only toothpaste (placebo)
Intervention Type
Drug
Intervention Name(s)
Triclosan, fluoride
Other Intervention Name(s)
Colgate Total Advanced Freshening toothpaste
Intervention Description
Six Month study, brush twice daily
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
Crest Cavity Protection toothpaste
Intervention Description
twice daily usage
Primary Outcome Measure Information:
Title
Gingivitis Index
Description
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)
Time Frame
6 months
Title
Plaque Index
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)
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Availability for the six-month duration of the study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.
Exclusion Criteria:
Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of
periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Use of antibiotics any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry
into the study.
Pregnant women or women who are breast feeding.
Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
History of allergic to personal care/consumer products or their ingredients.
Taking any prescription medicines. That might interfere with the study outcome.
Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augusto E Boneta, DDS
Organizational Affiliation
Dental Research Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Fernando Autran
City
Barcelona
Country
Spain
12. IPD Sharing Statement
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Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
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