NCT04964063

A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste

A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 655 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate changes in oral health-related quality of life (OHrQoL) in participants suffering from Dentinal Hypersensitivity (DH) symptoms following the use of anti-sensitivity toothpaste for 24 weeks.

Detailed description

This study will be a virtual, prospective, twenty-four weeks, open label study in participants with DH (self-reported symptoms). Participants self-perception of DH will be evaluated by completion of a validated OHrQoL questionnaire (Dentin Hypersensitivity Experience Questionnaire-48 \[DHEQ-48\]) at baseline, 4, 8, 12, 16, 20 and 24 weeks.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	Potassium Nitrate + Sodium Fluoride	Potassium Nitrate 5% weight/weight (w/w) and Sodium Fluoride 0.15% weight/volume (w/v) fluoride ion.

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-05-13
• Completion: 2022-05-13
• First posted: 2021-07-15
• Last updated: 2024-01-22
• Results posted: 2024-01-22

Locations

1 site across 1 country: United States