Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste
NCT ID: NCT06300866
Last Updated: 2024-03-08
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
80 participants
INTERVENTIONAL
2020-08-18
2021-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group I
toothpaste brushing 2x daily morning \& evening for 2 minutes
Test
test toothpaste containing 0.45% stannous fluoride
Control
toothpaste containing 0.76% sodium monofluorophosphate
Group II
toothpaste brushing 2x daily morning \& evening for 2 minutes
Test
test toothpaste containing 0.45% stannous fluoride
Control
toothpaste containing 0.76% sodium monofluorophosphate
Interventions
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Test
test toothpaste containing 0.45% stannous fluoride
Control
toothpaste containing 0.76% sodium monofluorophosphate
Eligibility Criteria
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Inclusion Criteria
* Subjects, ages 18-70, inclusive
* Availability for the six-month duration of the clinical research study
* Good general health
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
* Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
* Signed Informed Consent Form
Exclusion Criteria
* Presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
* 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 and/or drinking for periods up to 4 hours
* History of alcohol and/or drug abuse
* Self-reported pregnancy and/or lactating subjects.
18 Years
70 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Principal Investigators
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Yiming Li, DDS MSD PhD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University School of Dentistry
Loma Linda, California, United States
Countries
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Other Identifiers
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CRO-2020-04-PGN-LLU-YPZ
Identifier Type: -
Identifier Source: org_study_id
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