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Recruiting NCT07337109

A Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers

— Observational Dentin Hypersensitivity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dentin Hypersensitivity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Longitudinal Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers in the Real World

Overview

The primary purpose of this study is to characterize changes in Oral-Health-Related Quality of Life (OHrQoL), as measured by the Dentin Hypersensitivity Experience Questionnaire (DHEQ) over a 12-month period.

Detailed description

This will be a longitudinal study investigating OHrQoL and treatment patterns amongst new sufferers of self-reported Dentin Hypersensitivity (DH). Over the 12-month study duration, 375 participants suffering from DH will complete questionnaires online once per month.

Primary outcome measures

  • Change From Baseline in Total DHEQ Score Over 12 Months [Time frame: Baseline and up to 12 Months]
Secondary outcome measures (5)
  • Description of Treatment Selection Over 12 Months [Time frame: Up to 12 Months]
  • Treatment Discontinuation/Switch Over 12 Months [Time frame: Up to 12 Months]
  • Frequency of Treatment Used Over 12 Months [Time frame: Up to 12 Months]
  • Frequency of DH Over 12 Months [Time frame: Up to 12 Months]
  • Frequency of Brushing at Baseline, Months 6 and 12 [Time frame: Baseline, Months 6 and 12]

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 more than or equal to (>=)18 years.
  • Anyone who has begun to experience dentin hypersensitivity (self-reported) within the past three months.
  • Anyone who has started to use products to treat their tooth sensitivity within the past three months.
  • Participant who is able to independently complete all activities online.
  • Participants residing in the United States.

Exclusion criteria

  • Anyone who has any chronic health conditions that could impact their participation in this study, such as cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
  • Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
  • Anyone who suffers from tooth cavities, significant gum disease, cracked or fractured teeth, temporomandibular joint disease (TMD), or who has had tooth extractions or fillings within the last three months.
  • Anyone who wears braces (including Invisalign-like appliances) for treatment or dentures (full or partial).
  • 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.
  • Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
  • Participant who has been informed by a DHCP that they have active caries.
  • 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).
  • Anyone who has participated in another dentin hypersensitivity study within the last three months.
  • Currently participating in another research study or will be participating in any other research study at any point during this study's duration.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Citruslabs (Virtual Site) — Las Vegas

Identifiers

NCT: NCT07337109 · 400318

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗