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Meta-analysis of Stannous Fluoride Dentifrice and the Effects on Dentine Hypersensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04005417
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
The aim of this 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice.

Condition or disease Intervention/treatment
Dentine Hypersensitivity Drug: Stannous fluoride dentifrice Drug: Positive control dentifrice Drug: Negative control dentifrice

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Study Type : Observational
Actual Enrollment : 1036 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Stannous fluoride dentifrice
Twice daily brushing
Drug: Stannous fluoride dentifrice
Stannous fluoride (0.454%) dentifrice

Positive control dentifrice
Twice daily brushing
Drug: Positive control dentifrice
Positive control dentifrice containing potassium nitrate or arginine.

Negative control dentifrice
Twice daily brushing
Drug: Negative control dentifrice
Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

Primary Outcome Measures :
  1. Change from Baseline Air Challenge [ Time Frame: Up to 8 weeks ]
    The Schiff Sensitivity Scale is assessed for each test tooth via an evaporative air challenge. The examiner records the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.

  2. Change from Baseline in Tactile Threshold [ Time Frame: Up to 8 weeks ]
    Tactile Threshold is measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and is recorded as the threshold on the Tactile Sensitivity Score form.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This meta-analysis includes healthy adult male and females.

Subjects were excluded from this study for the following reasons;

  • severe periodontitis
  • at discretionary of the Principal Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04005417

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United States, Ohio
Multiple P&G Investigation Clinical Sites
Cincinnati, Ohio, United States, 45040
Sponsors and Collaborators
Procter and Gamble
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Responsible Party: Procter and Gamble Identifier: NCT04005417    
Other Study ID Numbers: 2019SnF2SensitivityAnalysis
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs