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

NCT04005417 | Completed FDA Drug

• 1 other identifier: 2019SnF2SensitivityAnalysis
• Study Type: observational
• Target: 1,036
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Stannous fluoride dentifrice

Twice daily brushing

Drug: Stannous fluoride dentifrice

Positive control dentifrice

Twice daily brushing

Drug: Positive control dentifrice

Negative control dentifrice

Twice daily brushing

Drug: Negative control dentifrice

Interventions

Stannous fluoride dentifrice DRUG

Stannous fluoride (0.454%) dentifrice

Stannous fluoride dentifrice

Positive control dentifrice DRUG

Positive control dentifrice containing potassium nitrate or arginine.

Positive control dentifrice

Negative control dentifrice DRUG

Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

Negative control dentifrice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This meta-analysis includes healthy adult male and females.

Subjects were excluded from this study for the following reasons; * severe periodontitis * at discretionary of the Principal Investigator

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Multiple P&G Investigation Clinical Sites

Cincinnati, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 2, 2019
• Study Start: January 8, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: July 2, 2019

Record last verified: 2019-07

Locations

US (1)