Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.
NCT ID: NCT07223060
Last Updated: 2025-10-31
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
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2017-05-17
2017-08-06
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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Test 1 toothpaste
0.454% stannous fluoride
brushed twice daily, morning and evening for 2 minutes eact time
Test 2 toothpaste
0.76% sodium monofluorophosphate
brushed twice daily, morning and evening for 2 minutes eact time
Interventions
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0.454% stannous fluoride
brushed twice daily, morning and evening for 2 minutes eact time
0.76% sodium monofluorophosphate
brushed twice daily, morning and evening for 2 minutes eact time
Eligibility Criteria
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Inclusion Criteria
* Subjects had to be in general good health
* Male and female adults between the ages of 18-70 (inclusive)
* Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns
* Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0
* Subjects had to be able to participate for the full duration (20 weeks) of the study
Exclusion Criteria
* Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity
* Moderate or advanced periodontal disease
* Five or more carious lesions requiring immediate care
* Use of antibiotics or steroids any time during one month prior to entry into the study
* Participation in any other clinical study or panel test
* Pregnant or breast feeding women
* History of allergies to dentifrice and personal care ingredients
* Allergies to dentifrice products
* Medical reasons that prohibit eating or drinking for 4 hours prior to clinical facility visit.
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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Dutmanee Seriwatanachai
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
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M U International Oral Science Research, Ltd.
Bangkok, Bangkok, Thailand
Countries
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Other Identifiers
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CRO-2017-04-TAR-SNDZ-YPZ
Identifier Type: -
Identifier Source: org_study_id