A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensi… (NCT03310268) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity
China185 participantsStarted 2017-11-18
Plain-language summary
The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduction of dentinal hypersensitivity (DH). This study will be considered successful if there is a statistically significant difference in the primary efficacy variable, change from baseline in Schiff sensitivity score, after 8 weeks of treatment.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Evidence of a personally signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any assessment is performed.
* Male and female participants who, at the time of screening, are between the ages of 18 and 70 years, inclusive.
* Participants who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
* Good general and mental health, in the opinion of the investigator or medically qualified designee.
* Male participants able to father children and female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female subjects who are not of childbearing potential must these meet requirements: Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state; have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
* The following oral and dental inclusions will apply at Screening (Visit 1): Self-reported history of dentinal …
What they're measuring
1
Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment