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

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ClinicalTrials.gov Identifier: NCT04005417
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Tracking Information
First Submitted Date July 1, 2019
First Posted Date July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date January 8, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Meta-analysis of Stannous Fluoride Dentifrice and the Effects on Dentine Hypersensitivity
Official Title Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This meta-analysis includes healthy adult male and females.
Condition Dentine Hypersensitivity
Intervention
  • Drug: Stannous fluoride dentifrice
    Stannous fluoride (0.454%) dentifrice
  • Drug: Positive control dentifrice
    Positive control dentifrice containing potassium nitrate or arginine.
  • Drug: Negative control dentifrice
    Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)
Study Groups/Cohorts
  • Stannous fluoride dentifrice
    Twice daily brushing
    Intervention: Drug: Stannous fluoride dentifrice
  • Positive control dentifrice
    Twice daily brushing
    Intervention: Drug: Positive control dentifrice
  • Negative control dentifrice
    Twice daily brushing
    Intervention: Drug: Negative control dentifrice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2019)
1036
Original Actual Enrollment Same as current
Actual Study Completion Date November 30, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Subjects were excluded from this study for the following reasons;

  • severe periodontitis
  • at discretionary of the Principal Investigator
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04005417
Other Study ID Numbers 2019SnF2SensitivityAnalysis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Procter and Gamble
Study Sponsor Procter and Gamble
Collaborators Not Provided
Investigators Not Provided
PRS Account Procter and Gamble
Verification Date July 2019