N/A
N=536
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
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT06045026 ↗Enrolled (actual)
536
Serious AEs
0.2%
Results posted
Apr 2025
Primary outcome: Primary: Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24 — -21.9; -35.4; -44.5; -51.6 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stannous fluoride (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24 |
-21.9; -35.4; -44.5; -51.6; -55.1; -62.0 | <0.0001 sig |
| PRIMARY Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-2.6; -4.7; -6.1; -7.2; -7.9; -8.5 | <0.0001 sig |
| PRIMARY Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-7.4; -12.6; -15.9; -18.6; -20.3; -22.9 | <0.0001 sig |
| PRIMARY Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-2.9; -4.6; -5.7; -6.6; -7.2; -8.1 | <0.0001 sig |
| PRIMARY Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-6.2; -9.6; -11.6; -13.2; -13.6; -15.4 | <0.0001 sig |
| PRIMARY Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-2.9; -3.9; -5.2; -5.9; -6.1; -7.1 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-1.3; -1.9; -2.2; -2.4; -2.5; -2.9 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-0.1; -0.1; -0.2; -0.2; -0.3; -0.3 | 0.0100 sig |
| SECONDARY Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-2.0; -3.2; -3.8; -4.2; -4.6; -5.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24 |
95.5; 48.0; 68.8; 27.6; 85.7; 36.7 | — |
| SECONDARY Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
-1.3; -1.5; -1.6; -2.2; -2.4; -2.7 | <0.0001 sig |
| SECONDARY Satisfaction Numeric Rating Scale (NRS) Score at Week 24 |
7.8 | — |
| SECONDARY Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline |
47; 394; 48; 2; 2; 489 | — |
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.
Eligibility Criteria
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 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06045026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.