A Real-World Evidence Study Evaluating Oral Health Related Quality of Life With Use of a Calcium Sodium Phosphosilicate Anti-Sensitivity Dentifrice for Dentin Hypersensitivity Management
HALEON
Summary
The aim of this study is to evaluate the impact of a commercially available desensitizing dentifrice containing 5 percent (%) Calcium sodium phosphosilicate (CSPS) on oral health related quality of life (OHrQoL) in a DH (Dentin Hypersensitivity) population in a real-world setting.
Description
This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms. OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participant. Sufficient numbers will be screened to enroll approximately 500 participants to ensure approximately 400 evaluable participants complete the entire study.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participant who has provided consent indicating they have been informed of all pertinent aspects of the study. * All genders who, at the time of screening, are aged 18 to 65. * Participant who is able to independently complete all activities on their smart devices * Participant who has tooth sensitivity (self-reported symptoms). Exclusion Criteria: * Participants whose tooth sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include: 1. Participant who has been/is on multiple prescriptio…
Interventions
- OtherCalcium sodium phosphosilicate (CSPS) Toothpaste
A toothpaste containing 5% weight/weight (w/w) calcium sodium phosphosilicate.
Location
- Citruslabs (Virtual Site)Las Vegas, Nevada