Back to resultsThe Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis
Primary Purpose
Dental Plaque, Gingivitis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
MFP Fluoride toothpaste
Stannous fluoride toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque
Eligibility Criteria
Inclusion Criteria:
- Subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the clinical research 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.
- Antibiotic use any time during the one-month period 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.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome.
- An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
- History of alcohol or drug abuse.
- Self-reported pregnant or lactating subjects.
Sites / Locations
- West China Dental Institute of Chengdu
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
MFP Fluoride toothpaste
Stannous Fluoride Toothpaste
Arm Description
Commercially available, monofluorophosphate (MFP) toothpaste. Fluoride level is 0.76%
New toothpaste containing 0.454% stannous fluoride.
Outcomes
Primary Outcome Measures
Dental Plaque Scores
Quigley-Hein, Turesky Modification 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)
Dental Plaque Scores
Quigley-Hein, Turesky Modification 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)
Dental Plaque Scores
Quigley-Hein, Turesky Modification 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)
Gingivitis Scores
Loe & Silness Gingival 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)
Gingivitis Scores
Loe & Silness Gingival 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)
Gingivitis Scores
Loe & Silness Gingival 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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852056
Brief Title
The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis
Official Title
The Clinical Investigation of a New Toothpaste Containing SnF as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in China
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.
Detailed Description
This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste.
Qualified subjects will be enrolled and randomized to either one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three and six months of product use. All subjects will be followed for adverse events throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Tooth brushing study. Subjects brush their whole mouth 2x/day for 1 minute each time. The study duration is 6 months
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
All clinical product will be in a plain white toothpaste tube or over wrapped with white laminate material to conceal any product identity. All study treatments will have a clinical label attached that contains study information and a unique product code.
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MFP Fluoride toothpaste
Arm Type
Placebo Comparator
Arm Description
Commercially available, monofluorophosphate (MFP) toothpaste. Fluoride level is 0.76%
Arm Title
Stannous Fluoride Toothpaste
Arm Type
Experimental
Arm Description
New toothpaste containing 0.454% stannous fluoride.
Intervention Type
Drug
Intervention Name(s)
MFP Fluoride toothpaste
Other Intervention Name(s)
Colgate Great Regular Flavor toothpaste
Intervention Description
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Intervention Type
Drug
Intervention Name(s)
Stannous fluoride toothpaste
Intervention Description
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Primary Outcome Measure Information:
Title
Dental Plaque Scores
Description
Quigley-Hein, Turesky Modification 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)
Time Frame
Baseline
Title
Dental Plaque Scores
Description
Quigley-Hein, Turesky Modification 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)
Time Frame
3 month
Title
Dental Plaque Scores
Description
Quigley-Hein, Turesky Modification 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)
Time Frame
6 month
Title
Gingivitis Scores
Description
Loe & Silness Gingival 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)
Time Frame
Baseline
Title
Gingivitis Scores
Description
Loe & Silness Gingival 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)
Time Frame
3 months
Title
Gingivitis Scores
Description
Loe & Silness Gingival 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)
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:
Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the clinical research 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.
Antibiotic use any time during the one-month period 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.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Self-reported pregnant or lactating subjects.
Facility Information:
Facility Name
West China Dental Institute of Chengdu
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis
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