Real-World Study of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Relief

Haleon

Status

Not yet enrolling

Conditions

Dentin Sensitivity

Treatments

Other: Calcium sodium phosphosilicate (CSPS) Toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT07300540

400303

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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 prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux.
2. Participant with full or partial denture.
3. Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
4. Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
5. Participants who have been informed by a DHCP that they have active caries.
6. Participant with any chronic and/or severe painful health condition which lead to regular use of pain relief medications (more than 3 days a week).
Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.