Clinical Research Study to Evaluate the Stain Removal Efficacy
NCT ID: NCT06242769
Last Updated: 2024-02-05
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
2020-07-27
2020-09-14
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
TREATMENT
TRIPLE
Study Groups
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Group I
Stannous Fluoride Toothpaste (SnF) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
Stannous Fluoride Toothpaste (SnF)
test
Colgate Fluoride Toothpaste (CDC)
negative control
Group II
Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush brushing 2 X day for 2 min
Stannous Fluoride Toothpaste (SnF)
test
Colgate Fluoride Toothpaste (CDC)
negative control
Interventions
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Stannous Fluoride Toothpaste (SnF)
test
Colgate Fluoride Toothpaste (CDC)
negative control
Eligibility Criteria
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Inclusion Criteria
* Good general health
* Male and female subjects, aged 21-70, inclusive
* Present 12 scoreable natural anterior teeth
* A minimum mean Composite Lobene Index score of 1 or greater
* Available for the duration of the study
* Clinical evidence of a tendency to form extrinsic stain on anterior teeth
Exclusion Criteria
* 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 or stain inducing medications 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
* Self-reported pregnancy and/or women who are breast feeding
* Dental prophylaxis received in the past four weeks prior to baseline examinations
* History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide
* On any prescription medicines that might interfere with the study outcome
* History of alcohol and/or drug abuse
* Exposed to a tooth whitening procedure during the last 3 months
21 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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Augusto R Elias-Boneta, DMD, MSD
Role: PRINCIPAL_INVESTIGATOR
Dental Research Associates, Inc
Locations
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Dental Research Associates, Inc.
San Juan, , Puerto Rico
Countries
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Other Identifiers
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CRO-2020-04-STN-SNF-PR-BGS
Identifier Type: -
Identifier Source: org_study_id
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