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

Haleon

Status: Completed

Conditions: Dentin Sensitivity

Treatments: Other: Stannous fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT06045026

300058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 536 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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536 participants in 1 patient group

Anti-sensitivity toothpaste

Other group

Description:

Participants will use the anti-sensitivity toothpaste according to the instructions on the commercial pack and their normal oral healthcare habits for 24 weeks.

Treatment:

Other: Stannous fluoride