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
NCT04964063
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2022-05-05
    Observational study model:
    Not applicable
    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 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32817
    Status
    Recruiting
    Contact us

    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
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