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

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

Study Description

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

Study Design

• 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

Groups and Cohorts

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%)

Outcome Measures

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.

Eligibility Criteria

• 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.

Criteria

Subjects were excluded from this study for the following reasons;

• severe periodontitis
• at discretionary of the Principal Investigator

Contacts and Locations

Locations

United States, Ohio

Multiple P&G Investigation Clinical Sites

Cincinnati, Ohio, United States, 45040

Sponsors and Collaborators

Procter and Gamble

More Information

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT04005417 History of Changes
• Other Study ID Numbers: 2019SnF2SensitivityAnalysis
• First Posted: July 2, 2019
• Last Update Posted: July 2, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dentin Sensitivity; Hypersensitivity; Immune System Diseases; Tooth Diseases; Stomatognathic Diseases; Fluorides; Tin Fluorides; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs