NCT07337109招募中不适用
A Longitudinal Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers in the Real World
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- HALEON
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total DHEQ Score Over 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
New sufferers of self-reported Dentin Hypersensitivity aged 18+ years
结局指标
主要结局
Change From Baseline in Total DHEQ Score Over 12 Months
时间窗: Baseline and up to 12 Months
Change from baseline in total DHEQ score and each of the domain scores (daily restrictions, coping behaviors, personal identity, social impact, emotional impact) over 12 months. The DHEQ has total 15 questions each will be scored on a scale ranging from 1 (strongly disagree) to 7 (strongly agree), thus total possible score will be ranging from 15 to 105, where higher score indicates worst outcome.
次要结局
- Description of Treatment Selection Over 12 Months(Up to 12 Months)
- Treatment Discontinuation/Switch Over 12 Months(Up to 12 Months)
- Frequency of Treatment Used Over 12 Months(Up to 12 Months)
- Frequency of DH Over 12 Months(Up to 12 Months)
- Frequency of Brushing at Baseline, Months 6 and 12(Baseline, Months 6 and 12)
研究者
研究点 (1)
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