The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis
NCT ID: NCT03852056
Last Updated: 2019-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2017-05-25
2017-12-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MFP Fluoride toothpaste
Commercially available, monofluorophosphate (MFP) toothpaste. Fluoride level is 0.76%
MFP Fluoride toothpaste
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Stannous Fluoride Toothpaste
New toothpaste containing 0.454% stannous fluoride.
Stannous fluoride toothpaste
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Interventions
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MFP Fluoride toothpaste
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Stannous fluoride toothpaste
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Availability for the six-month duration of the clinical research study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.
Exclusion Criteria
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Antibiotic use any time during the one-month period prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Dental prophylaxis during the past two weeks prior to baseline examinations.
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome.
11. An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
12. History of alcohol or drug abuse.
13. Self-reported pregnant or lactating subjects.
18 Years
70 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Locations
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West China Dental Institute of Chengdu
Chengdu, Sichuan, China
Countries
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Other Identifiers
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CRO-2017-02-GIN-SNDZ-YPZ
Identifier Type: -
Identifier Source: org_study_id
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