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

Haleon

Status: Completed

Conditions: Dentin Sensitivity

Treatments: Other: Potassium Nitrate + Sodium Fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT04964063

216953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 655 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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655 participants in 1 patient group

Sensodyne Fresh Mint Toothpaste

Other group

Description:

Participants will be asked to follow commercial tube instructions as recommended for sensitivity relief: "Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing, Spit out after brushing."

Treatment:

Other: Potassium Nitrate + Sodium Fluoride