The Interactive Distraction Technique for Controlling Gag Reflex During Endodontic Diagnostic Radiography of Posterior Teeth: A Split-Mouth Randomized Controlled Clinical Trial With Patients Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Severity of gagging
研究概览
简要总结
Intraoral radiography plays a vital role in endodontic diagnosis and treatment planning. However, many patients experience discomfort during periapical radiographic procedures due to factors such as a pronounced gag reflex and dental anxiety, making the process difficult and distressing. Managing these issues is essential for enhancing patient cooperation and improving overall treatment experience.
This study investigates the potential of Virtual Reality (VR) interactive distraction as a noninvasive method to control gag reflex and improve patient comfort during intraoral radiography. While VR has shown promise in reducing dental anxiety in various procedures, its effectiveness in managing gag reflex during diagnostic endodontic radiography remains largely unexplored.
The primary objective of this study is to evaluate the effectiveness of VR in reducing the gag reflex in adult patients undergoing routine periapical radiographs for maxillary molar teeth. Secondary objectives include assessing patient preferences, experiences, and satisfaction associated with the use of VR.
The study involves patients who require bilateral intraoral diagnostic radiographs of maxillary molars. Each patient will undergo two radiographs: one with standard procedure (Control - Group 1), and the other using VR distraction (Experimental - Group 2). A randomized, computer-generated list will determine which side will receive the VR intervention.
Gag reflex scores will be measured before and after the procedure, pre- and post-procedure anxiety levels will be recorded using Modified Dental Anxiety Scale (MDAS). Additionally, a structured questionnaire will assess patient satisfaction and experience with the VR device. Physiological indicators such as pulse rate, blood pressure, and oxygen saturation will be recorded to evaluate any changes associated with the use of VR.
This study aims to generate evidence on whether VR distraction can be an effective tool for controlling gag reflex and improving patient tolerance, ultimately enhancing the quality of care in diagnostic dental radiography.
详细描述
Background:
Intraoral radiography is crucial for accurate endodontic diagnosis and treatment planning. However, some patients face challenges during periapical radiography procedures. Many struggle to tolerate the placement of intraoral films or sensors; a problem worsens because of gag reflexes and dental anxiety.
Rationale:
Controlling gag reflexes, improving patient experience, and reducing anxiety are priorities in all dental procedures. Virtual reality (VR) interactive distraction is a promising noninvasive tool to improve patient experience and reduce anxiety during dental procedures. So far, little to no evidence exists regarding the impact of VR on controlling gag reflex in patients undergoing diagnostic endodontic intraoral radiography procedures.
Study objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patients (over 18 years old) visiting the Al-Rass dental clinics of the College of Dentistry and undergoing bilateral maxillary molar periapical radiographs for endodontic diagnostic purposes.
- •Patients who are willing to collaborate in the study and willing to sign the written informed consent.
- •Classified as class I, II according to the American Society of Anesthesiologists Physical Status Classification System.
- •Patients exhibiting a gag reflex of "moderate" to "very severe" according to the classification of the Gagging Problem (CGP) index
排除标准
- •Mentally or medically compromised patients.
- •Patients with acute pain, such as acute pulpitis, which require emergency treatment.
- •Pregnant women.
- •Patients on any medications for the past two weeks.
- •Patients who refuse to participate in the study.
研究组 & 干预措施
Group 1. Periapical radiograph without virtual reality (VR) distraction
In this group an experienced endodontist will take Digital periapical radiographs using photostimulable phosphor plates (DigoraOptime, Soredex Medical Systems, Helsinki, Finland), with a holder for standardization and a paralleling technique for ortho-radial projection at a focus-receptor distance of 20 cm. The size of the plates will be selected according to the patient's arch size. Plates will be exposed using a De Gotzen X-Mind® Unity X-ray unit (De Gotzen Srl, Olgiate Olona, Italy), set at 70 kVp and 8 mA, with an exposure time of 0.25 seconds. The radiograph will be taken.
干预措施: Periapical radiograph will be taken without VR (Other)
Group 2. Periapical radiograph with virtual reality (VR) distraction
In this group all steps will remain the same as comparator group except that periapical radiograph will be taken using following virtual reality (VR) distraction approach.
An Oculus Quest VR headset will be used in this study. Each participant will be briefly instructed regarding the interactive distraction VR device. The VR headset will be loaded with a short, animated movie, which will be shown to each participant in the experimental group (G2) two minutes before the procedure. Each patient will fill out a modified dental anxiety scale prior to radiography procedures.
干预措施: Periapical radiograph will be taken with VR (Device)
结局指标
主要结局
Severity of gagging
时间窗: Baseline (pre-procedure) and periprocedural (during X-ray film placement) on Day 1.
The 5-point Gagging Severity (GS) Scale will be used to assess the change in gagging response between the two study arms. In this scale, G1 = no gagging and G5 = very severe gagging; higher scores indicate a worse gag reflex.
次要结局
- Dental anxiety(Immediately before and immediately after the radiographic procedure (Day 1).)
- Physiological response (pulse rate, blood pressure, and oxygen saturation)(Before, during, and after the radiographic procedure (Day 1).)
- Patient preferences, experiences, and satisfaction(Immediately after X-ray film placement (post-procedural, Day 1).)
研究者
Muhammad Zubair Ahmad
Associate Professor
Qassim University