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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Change From Baseline in Total DHEQ Score Over 12 Months [Срок оценки: Baseline and up to 12 Months]

Вторичные конечные точки (5)

• Description of Treatment Selection Over 12 Months [Срок оценки: Up to 12 Months]
• Treatment Discontinuation/Switch Over 12 Months [Срок оценки: Up to 12 Months]
• Frequency of Treatment Used Over 12 Months [Срок оценки: Up to 12 Months]
• Frequency of DH Over 12 Months [Срок оценки: Up to 12 Months]
• Frequency of Brushing at Baseline, Months 6 and 12 [Срок оценки: Baseline, Months 6 and 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Citruslabs (Virtual Site) — Las Vegas

Идентификаторы

NCT: NCT07337109 · 400318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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