Status:
COMPLETED
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
Lead Sponsor:
HALEON
Conditions:
Dentin Sensitivity
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Detailed 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 over ...
Eligibility Criteria
Inclusion
- 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 between 18 and 65 years (inclusive).
- Participant who is willing to complete all the assigned activities.
- Participant who is able to independently complete all the assigned activities on their smart devices.
- Participant who has tooth sensitivity (self-reported symptoms).
Exclusion
- Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
- 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.
- Participant with full or partial denture(s).
- 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.
- Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
- Participant who has been informed by a DHCP that they have active caries.
- Participant with any chronic and/or severe painful health condition(s) 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.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT06045026
Start Date
September 21 2023
End Date
April 25 2024
Last Update
April 24 2025
Active Locations (1)
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1
ObvioHealth Virtual Site
New York, New York, United States, 10001