N/A
N=655
A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste
Dentin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT04964063 ↗Enrolled (actual)
655
Serious AEs
0.3%
Results posted
Jan 2024
Primary outcome: Primary: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) — 5.90; 6.17; 5.20 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potassium Nitrate + Sodium Fluoride (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) |
5.90; 6.17; 5.20 | — |
| PRIMARY Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4 |
4.54; 4.51; 3.98 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8 |
4.06; 3.99; 3.74 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12 |
3.61; 3.55; 3.33 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16 |
3.34; 3.26; 3.14 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20 |
3.20; 3.18; 3.02 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24 |
2.96; 2.93; 2.81 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0) |
165.20 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4 |
145.31 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8 |
133.93 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12 |
125.41 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16 |
120.48 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20 |
116.98 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24 |
112.62 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0) |
21.56 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4 |
18.92 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8 |
17.28 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12 |
15.80 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16 |
15.04 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20 |
14.52 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24 |
14.11 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0) |
59.33 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4 |
52.34 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8 |
47.80 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12 |
44.71 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16 |
42.71 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20 |
41.59 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24 |
40.48 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0) |
21.35 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4 |
18.95 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8 |
17.64 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12 |
16.61 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16 |
16.06 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20 |
15.68 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24 |
15.08 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0) |
41.10 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4 |
35.42 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8 |
32.55 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12 |
30.48 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16 |
29.43 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20 |
28.42 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24 |
27.18 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0) |
21.86 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4 |
19.68 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8 |
18.66 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12 |
17.82 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16 |
17.24 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20 |
16.76 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24 |
15.78 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0) |
2.90 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4 |
2.83 | 0.1091 |
| PRIMARY Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8 |
2.78 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12 |
2.74 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16 |
2.72 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20 |
2.69 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24 |
2.65 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0) |
8.52 | — |
| PRIMARY Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4 |
6.71 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8 |
5.81 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12 |
5.41 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16 |
5.05 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20 |
4.69 | <.0001 sig |
| PRIMARY Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24 |
4.25 | <.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Provision of consent indicating that the participant has been informed of all pertinent aspects of the study.
- The participant must be able to complete all activities as shown in the Schedule of Activities independently on their smart devices.
- Participant who has tooth sensitivity (self-reported symptoms).
Exclusion Criteria
- A participant whose sensitivity could be caused by other factors or clinical pathology as established by the screening questionnaire, which also includes:
- A participant who has been/is on multiple prescription medications to treat severe acid reflux on regular basis or considered surgery for acid reflux
- A participant with full or partial denture
- A participant who has undergone treatment within 6 months of screening or is currently under treatment for periodontal or gum disease
- A participant with active periodontitis
- A participant with active caries
- A participant with any chronic and/or severe painful health conditions which lead to regular use pain medications (more than 3 days a week)
- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients: potassium nitrate (5 percent [%]), sodium fluoride (0.15% weight/volume [w/v] fluoride ion), water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1.
Data sourced from ClinicalTrials.gov (NCT04964063). 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.