Last updated: 11/22/2021 06:00:05
A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste
GSK study ID
216953
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) Section 1 - Impact on everyday life (Question [Q]1-3) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 1 - Impact on everyday life (Q1-3) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 1 - Impact on everyday life (Q1-3) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 1 - Impact on everyday life (Q1-3) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 1 - Impact on everyday life (Q1-3) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 1 - Impact on everyday life (Q1-3) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 1 - Impact on everyday life (Q1-3) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Total Score (Q1-34) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Total Score (Q1-34) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Total Score (Q1-34) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Total Score (Q1-34) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Total Score (Q1-34) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Total Score (Q1-34) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Total Score (Q1-34) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Restrictions (Q1-4) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Restrictions (Q1-4) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Restrictions (Q1-4) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Restrictions (Q1-4) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Restrictions (Q1-4) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Restrictions (Q1-4) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Restrictions (Q1-4) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Adaptation (Q5-16) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Adaptation (Q5-16) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Adaptation (Q5-16) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Adaptation (Q5-16) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Adaptation (Q5-16) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Adaptation (Q5-16) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Adaptation (Q5-16) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Social Impact (Q17-21) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Social Impact (Q17-21) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Social Impact (Q17-21) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Social Impact (Q17-21) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Social Impact (Q17-21) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Social Impact (Q17-21) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Social Impact (Q17-21) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Emotional Impact (Q22-29) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Emotional Impact (Q22-29) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Emotional Impact (Q22-29) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Emotional Impact (Q22-29) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Emotional Impact (Q22-29) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Emotional Impact (Q22-29) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Emotional Impact (Q22-29) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Identity (Q30-34) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Identity (Q30-34) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Identity (Q30-34) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Identity (Q30-34) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Identity (Q30-34) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Identity (Q30-34) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Identity (Q30-34) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Global Oral Health Score (Q35) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Global Oral Health Score (Q35) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Global Oral Health Score (Q35) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Global Oral Health Score (Q35) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Global Oral Health Score (Q35) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Global Oral Health Score (Q35) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Global Oral Health Score (Q35) at Week 24
Timeframe: Week 24
Mean Score of DHEQ Section 2 – Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Score of DHEQ Section 2 – Effect of Life Overall Score (Q36 - 39) at Week 4
Timeframe: Week 4
Mean Score of DHEQ Section 2 – Effect of Life Overall Score (Q36 - 39) at Week 8
Timeframe: Week 8
Mean Score of DHEQ Section 2 – Effect of Life Overall Score (Q36 - 39) at Week 12
Timeframe: Week 12
Mean Score of DHEQ Section 2 – Effect of Life Overall Score (Q36 - 39) at Week 16
Timeframe: Week 16
Mean Score of DHEQ Section 2 – Effect of Life Overall Score (Q36 - 39) at Week 20
Timeframe: Week 20
Mean Score of DHEQ Section 2 – Effect of Life Overall Score (Q36 - 39) at Week 24
Timeframe: Week 24
Secondary outcomes:
Not applicable
Interventions:
Other: Potassium Nitrate + Sodium Fluoride
Enrollment:
650
Observational study model:
Not applicable
Primary completion date:
2022-05-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentin Sensitivity
Product
potassium nitrate, potassium nitrate/sodium fluoride, sodium fluoride
Collaborators
Not applicable
Study date(s)
August 2021 to May 2022
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
No
- 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.
- 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
Inclusion and exclusion 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 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.
A participant whose sensitivity could be caused by other factors or clinical pathology as established by the screening questionnaire, which also includes:
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website