试验雷达 AI | ||
|---|---|---|
临床试验 NCT07493200 针对Gag Reflex目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment 40
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07493200是一项针对Gag Reflex的干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2025年5月12日，计划招募40名患者。该研究由Beyhan Başkan主导，预计于2026年4月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月25日。
简要概括
Background:
Root canal treatment is a common dental procedure used to save infected teeth. However, some patients experience a strong gag reflex during the treatment. This reflex can make it very difficult for the dentist to work, cause significant stress for the patient, and prolong the procedure. Current methods to control the gag reflex, such as anesthesia or sedation, can be complicated, require special equipmen...
显示更多官方标题
The Effect of Using Custom-Made Silicone Earplips on Gag Reflex Severity, Behavioral Responses, and Salivary Alpha-Amylase Levels as a Stress Biomarker in Patients Undergoing Root Canal Treatment: A Randomized Controlled Trial
疾病
Gag Reflex出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- HRÜ724.09.54
NCT编号
实际开始日期
2025-05-12
最近更新发布
2026-03-25
预计完成日期
2026-04-30
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中（不再招募）
关键词
Salivary Alpha-Amylase
Root Canal Treatment
Randomized Controlled Trial
Root Canal Treatment
Randomized Controlled Trial
主要目的
其他
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Experimental Group Patients in this group (n=20) will have a custom-made silicone earplug placed in the ear opposite the side where the dentist is working during their root canal treatment. The earplug is fabricated immediately before the procedure using soft silicone material to ensure a comfortable, personalized fit. No other pharmacological or behavioral interventions for gag reflex control will be used. | Custom-Made Silicone Earplug A personalized earplug fabricated from a soft, two-component addition-cure silicone (C-type silicone), commonly used for dental impressions. The two components are mixed according to the manufacturer's instructions and gently injected into the patient's external auditory canal on the side contralateral to the tooth receiving treatment. The silicone is allowed to polymerize for approximately 2-3 minutes, creating a cu...显示更多 |
无干预Control Group Patients in this group (n=20) will receive standard root canal treatment without any earplug placement. No interventions for gag reflex control will be used. All outcome measures (gag reflex severity, behavioral responses, treatment pause ratio, salivary alpha-amylase) will be collected in the same manner as for the experimental group. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gag Reflex Severity | The severity of the gag reflex will be assessed using the Dickinson and Fiske Gagging Severity Index, a 5-point ordinal scale: 1=Normal (very mild, occasional, controllable by patient), 2=Mild (control achieved with support from dental team), 3=Moderate (consistent, limits treatment options), 4=Severe (occurs with any type of treatment, including simple visual examination), 5=Very Severe (affects patient behavior and dental visits, makes treatment impossible). The score will be recorded by the operator at the most challenging point of the root canal procedure (e.g., during rubber dam placement or access cavity preparation). | At the time of the root canal procedure (single time point during the most challenging part of treatment) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Behavioral Response Score | Patient discomfort will be assessed by a trained observer (blinded to group allocation) who will record the presence or absence of 8 specific behavioral signs of distress during the procedure: (1) eye squeezing, (2) sweating (forehead or upper lip), (3) muscle tension (hand clenching, leg movements), (4) withdrawal/attempts to avoid treatment, (5) groaning, (6) crying, (7) breath-holding, (8) increased saliva production. The total score (0-8) is calculated by summing the number of observed signs. This total score is further categorized as mild (0-2), moderate (3-4), severe (5-6), or very severe (7-8) for analysis. | Throughout the root canal procedure (continuous observation) |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Adult patients aged 18 years and older.
- Patients requiring non-surgical root canal treatment on a permanent tooth.
- Patients classified with a severe (score 4) or very severe (score 5) gag reflex according to the Dickinson and Fiske Gagging Severity Index.
- Patients who provide written informed consent to participate in the study.
- Patients with a mild or moderate gag reflex (Dickinson and Fiske scores 1, 2, or 3).
- Patients with any known ear pathology, anatomical anomaly of the ear canal, or active ear infection that would preclude the use of an earplug.
- Patients with a history of vertigo or balance disorders.
- Patients with medical conditions that could affect salivary flow or composition (e.g., Sjögren's syndrome, uncontrolled diabetes).
- Patients taking medications that could influence salivary alpha-amylase levels (e.g., systemic corticosteroids, psychotropic drugs).
- Pregnant or breastfeeding women.
- Patients unable to provide informed consent or comply with the study protocol.
Beyhan Başkan研究责任方
Beyhan Başkan, 申办者-研究者, Assistant Professor, Kahramanmaras Sutcu Imam University
没有联系数据。
1 位于 1 个国家/地区的研究中心
Kahramanmaraş Sütçü İmam Universty, Kahramanmaraş, 46140, Turkey (Türkiye)