Actively Recruiting
A Real-World Evidence Study Evaluating Oral Health Related Quality of Life with Use of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Management
Led by HALEON ยท Updated on 2026-03-11
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a commercially available toothpaste containing 5% Calcium sodium phosphosilicate (CSPS) on the oral health-related quality of life (OHrQoL) in adults with dentin hypersensitivity (DH). This open-label, prospective study aims to understand how this toothpaste influences the daily experiences of people with self-reported sensitive teeth over a real-world setting. Approximately 500 participants will be screened to enroll around 400 who complete the study. Participants will use the test toothpaste twice daily, brushing their teeth no more than three times per day, for a total of 24 weeks. This study is decentralized and monadic in design, meaning all participants will receive the same toothpaste without a comparison group. The main focus is on observing changes in quality of life related to tooth sensitivity as participants use the product. During the study, participants will complete the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48) at multiple time points including baseline and week 24, to assess various impacts of dentin sensitivity on their lives. Researchers will monitor changes in pain, social and emotional effects, and daily life restrictions caused by tooth sensitivity. Safety and satisfaction will also be evaluated throughout the 24-week period.
CONDITIONS
Brief Title
Real-World Study of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Relief
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- Participants whose tooth sensitivity could be caused by other factors or clinical pathology than dentin hypersensitivity, as self-reported.
- Participant who has been or is on multiple prescription medications to treat severe acid reflux regularly or has had surgery for acid reflux.
- Participant with full or partial denture.
- Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment.
- Participant informed by a dental professional that they have active periodontitis.
- Participant informed by a dental professional that they have active caries.
- Participant with any chronic or severe painful health condition leading to regular use of pain relief medication more than 3 days a week.
- Participant with known or suspected intolerance or hypersensitivity to the study materials or any ingredients.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
Duration - 24 weeks
Participants use the test toothpaste by brushing their teeth twice daily and not more than three times per day for dentin hypersensitivity relief.
Baseline and weekly remote assessments at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Trial Site Locations
Total: 1 location
1
Citruslabs (Virtual Site)
Las Vegas, Nevada, United States, 89118
Actively Recruiting
Research Team
H
Haleon Response Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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