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

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Haleon

Status

Completed

Conditions

Dentin Sensitivity

Treatments

Other: Potassium Nitrate + Sodium Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

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)

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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