Clinical trial NCT06045026: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 536
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: 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.

Detailed description: This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms over 24 weeks of use of a DH treatment (anti-sensitivity toothpaste). OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participants at Baseline, and Weeks 4, 8, 12, 16, 20, 24.

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:

  1. 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.
  2. Participant with full or partial denture(s).
  3. 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.
  4. Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
  5. Participant who has been informed by a DHCP that they have active caries.
  6. 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.

Primary outcomes:
measure: Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Secondary outcomes:
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: 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
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
measure: 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
timeFrame: Baseline (Week 0) and Week 24
measure: Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
timeFrame: Baseline (Week 0) and Weeks 1, 2, 4, 8, 12, 16, 20, 24
measure: Satisfaction Numeric Rating Scale (NRS) Score at Week 24
timeFrame: Week 24
measure: Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
timeFrame: Baseline (Week 0)
Other outcomes:
Locations:
city: New York
country: United States
facility: ObvioHealth Virtual Site
state: New York
Study officials:
References: