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

Completed

• Conditions: Dentine Hypersensitivity
• Interventions: Drug: Stannous fluoride dentifrice; Drug: Positive control dentifrice; Drug: Negative control dentifrice

• Registration Number: NCT04005417
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Last Update Submitted: 2019-07-01
• Study First Posted: 2019-07-02
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1036

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stannous fluoride dentifrice	Stannous fluoride dentifrice	Twice daily brushing
Positive control dentifrice	Positive control dentifrice	Twice daily brushing
Negative control dentifrice	Negative control dentifrice	Twice daily brushing

Primary Outcome Measures

Name	Time	Method
Change from Baseline Air Challenge	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	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.

Trial Locations

Locations (1)

Multiple P&G Investigation Clinical Sites; 🇺🇸 Cincinnati, Ohio, United States