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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04005417
Other study ID # 2019SnF2SensitivityAnalysis
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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