Validating a Questionnaire for the Identification of Possible Trigeminal Neuralgia in Dental Practice
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of the IDTN Questionnaire
研究概览
简要总结
Trigeminal neuralgia (TN) is a severe type of non-dental orofacial pain that can feel like sudden electric shocks in the face and is often mistaken for tooth pain or other dental problems. This can lead to delays in referral and unnecessary, sometimes irreversible, dental treatment. The goal of this observational study is to evaluate how well a new questionnaire (IDentification of possible Trigeminal Neuralgia - IDTN) identifies adults with possible trigeminal neuralgia among patients attending hospital clinics with orofacial pain, with the aim of supporting its use in dental and general medical practice to improve early recognition and referral.
The main questions it aims to answer are:
- How accurately does the IDTN questionnaire identify patients with possible trigeminal neuralgia compared with the specialist clinical diagnosis?
- Which combination of questionnaire items best supports a practical screening score for use in dental and/or general medical practice?
Participants will:
- Complete the IDTN questionnaire before their clinical appointment (either electronically or on paper)
- Undergo their usual specialist clinical assessment, during which the final diagnosis will be recorded
- Allow the research team to compare questionnaire responses with the specialist diagnosis (the reference standard)
A subset of participants will also be asked to complete the questionnaire again a few days later to assess test-retest reliability.
详细描述
Trigeminal neuralgia (TN) is a severe neuropathic facial pain condition that is often difficult to recognize early, especially in primary care and dental settings. Many patients initially present with pain that can be mistaken for dental disease or other types of non-dental pain, such as temporomandibular disorders, which may lead to delays in diagnosis and inappropriate dental treatment. A practical screening tool for use in dental practice may support earlier identification and referral of patients with possible TN.
This study will evaluate the diagnostic accuracy of a newly developed questionnaire, the IDentification of possible Trigeminal Neuralgia (IDTN) tool. The IDTN questionnaire was developed with input from patients, dentists, and clinical experts and is designed to capture key features of TN, including pain quality, paroxysmal attacks, pain location, triggers, and related clinical characteristics. This is the first validation study of this tool in a real-world clinical setting. Currently, there is no similar screening tool that has been validated and widely accepted for use in dental practice.
Study Design This is a single-site, prospective, observational diagnostic validation study conducted at University College London Hospitals (UCLH) NHS (National Health System) Foundation Trust, including the Facial Pain Service and Oral Surgery clinics. Adult patients attending for a first appointment with facial or oral pain will be invited to participate. The study is non-interventional and does not alter routine clinical care.
Study Procedures
Participants will complete the 15-item IDTN questionnaire before their specialist consultation, either:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Adults aged 18 years or older
- •Attending the UCLH Facial Pain Service or Oral Surgery Clinic for their first appointment for facial or oral pain following referral from primary care
排除标准
- •Not experiencing facial or oral pain
- •Unable to understand English well enough to complete the questionnaire
- •Lacking capacity to provide informed consent
- •Insufficient time before their appointment to read the information sheet, provide consent, and complete the questionnaire
研究组 & 干预措施
Adults With Orofacial Pain
Adults aged 18 years or older attending the University COllege London Hospital (UCLH) Facial Pain Service or the Oral Surgery Clinic for their first appointment for facial or oral pain. All participants will complete the IDTN questionnaire before their routine clinical consultation. Their specialist diagnosis (for example, trigeminal neuralgia or other facial/oral pain condition) will be used as the reference standard to assess the accuracy of the questionnaire.
干预措施: Completion of the IDTN Questionnaire (Other)
结局指标
主要结局
Diagnostic Accuracy of the IDTN Questionnaire
时间窗: Day 1 (at the participant's clinic appointment)
Sensitivity and specificity of the IDTN screening tool for identifying possible trigeminal neuralgia (TN), using the specialist clinical diagnosis as the reference standard. This will assess how accurately the questionnaire distinguishes between participants with and without possible TN.
次要结局
- Positive and Negative Predictive Values(Day 1)
- Receiver operating characteristic (ROC) curve and area under the curve (AUC)(Day 1)
- Internal Consistency Reliability(Through study completion (after all questionnaires are collected) (average 1 year))
- Test - Retest Reliability(2-3 days after initial questionnaire completion)
- Refinement of Questionnaire Items(Through study completion (on average within 6 months after final participant visit))
- Validity(Day 1)