Clinical Trial: A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management

Study Status: ACTIVE_NOT_RECRUITING
Recruit Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL

Official Title: A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management

Brief Summary: This study will evaluate the impact of long-term use of a desensitizing toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) on oral health related quality of life (OHrQoL) in a population of self-reported dentin hypersensitivity (DH) sufferers.
Data generated will provide real world information on the DH experience and DH management with a daily use anti-sensitivity treatment.

Detailed Summary: 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 over 24 weeks of use of a DH treatment (anti-sensitivity toothpaste).
OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participants at Baseline, and Weeks 4, 8, 12, 16, 20, 24.
Sponsor: HALEON

Current Primary Outcome: The DHEQ is a condition-specific measure of OHrQoL in relation to DH which contains total 34 questions in section 2, each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Thus, the total score ranges from 34 to 238, where lower score indicates improvement in the symptoms.
Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Original Primary Outcome: The DHEQ is a condition-specific measure of OHrQoL in relation to DH which contains total 34 questions in section 2, each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Thus, the total score ranges from 34 to 238, where lower score indicates improvement in the symptoms.
Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: HALEON

Dates:
Date Received: September 13, 2023
Date Started: September 21, 2023
Date Completion: September 21, 2023
Last Updated: November 20, 2023
Last Verified: November 01, 2023