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

Dentine Hypersensitivity Clinical Trial

Official title:

Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005417
• Other study ID #: 2019SnF2SensitivityAnalysis
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: July 2019
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1036
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Subjects were excluded from this study for the following reasons;

• severe periodontitis

• at discretionary of the Principal Investigator

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Stannous fluoride dentifrice
Stannous fluoride (0.454%) dentifrice
• Positive control dentifrice
Positive control dentifrice containing potassium nitrate or arginine.
• Negative control dentifrice
Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

Locations

Country	Name	City	State
United States	Multiple P&G Investigation Clinical Sites	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Air Challenge	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.	Up to 8 weeks
Primary	Change from Baseline in Tactile Threshold	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.	Up to 8 weeks