Clinical trial NCT04964063: A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste
Official title: A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 655
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study will be a virtual, prospective, twenty-four weeks, open label study in participants with DH (self-reported symptoms). Participants self-perception of DH will be evaluated by completion of a validated OHrQoL questionnaire (Dentin Hypersensitivity Experience Questionnaire-48 \[DHEQ-48\]) at baseline, 4, 8, 12, 16, 20 and 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.

Primary outcomes:
measure: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24
timeFrame: Week 24
measure: Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4
timeFrame: Week 4
measure: Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8
timeFrame: Week 8
measure: Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12
timeFrame: Week 12
measure: Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16
timeFrame: Week 16
measure: Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20
timeFrame: Week 20
measure: Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
Study officials:
affiliation: OBVIO HEALTH USA, Inc.
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: