Efficacy of Manual Toothbrushes in Removing Tooth Stains
NCT ID: NCT06486974
Last Updated: 2024-09-25
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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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2024-09-23
2024-10-31
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
QUADRUPLE
Study Groups
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Group 1
Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F)
Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush
NaF
Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
Group 2
Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F)
Colgate Adult Extra Clean soft-bristle toothbrush
Na MFP
Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
Interventions
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NaF
Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
Na MFP
Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study
Eligibility Criteria
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Inclusion Criteria
* Male and female subjects, aged 18-70, inclusive;
* Good general health and good oral health based on the opinion of the study investigator;
* Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
* A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
* Available for the duration of the study;
* Clinical evidence of a tendency to form extrinsic stains on anterior teeth.
Exclusion Criteria
* Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
* Tumor(s) of the soft or hard tissues of the oral cavity;
* Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
* Five or more carious lesions requiring immediate care;
* Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
* Concurrent participation in another clinical study;
* Self-reported pregnancy and/or lactating women;
* Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
* History of allergies to oral care/personal care consumer products or their ingredients;
* History of alcohol and/or drug abuse.
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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Franklin Garcia-Godoy, DDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
Global Research Consultants
Locations
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Spa Dental
Santo Domingo, , Dominican Republic
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRO-2024-08-STN-DRW-DR-BGS
Identifier Type: -
Identifier Source: org_study_id
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