A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste

A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management

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.

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.

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.