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Completed

NCT Number: NCT07236138

Controlling Gag Reflex During Endodontic Diagnostic Radiography

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.

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Key information

Conditions

Gagging Anxiety Anxiety Disorders Behavior Dental Pulp Diseases Endodontic Disease Health Behavior Mental Disorders Pathological Conditions, Signs and Symptoms Patient Satisfaction Satisfaction, Patient Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases Tooth Diseases Treatment Adherence and Compliance Xray Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professor Muhammad Zubair Ahmad

Ar Rass, Al-Qassim Region, 58883, Saudi Arabia

About this study

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:

As its primary objective, this study will evaluate the use of VR interactive distraction to control the gag reflex in adult patients undergoing routine endodontic diagnostic intraoral radiography for maxillary molar teeth. As its secondary objectives, the study will evaluate the impact of VR on patients' preferences, experiences, and satisfaction as well as anxiety levels.

Methods:

The study will be conducted on patients who require endodontic bilateral diagnostic intraoral radiographs of maxillary molar teeth for reasons not related to this study. Two radiographs will be taken for each patient as follows.

  • Control (G1) - Periapical radiograph without application of VR distraction.
  • Experimental (G2) - Periapical radiograph with the application of VR distraction.

A computer-generated list will be used to randomly select the control and experimental sides. Modified Dental Anxiety Scale (MDAS) will be used to assess anxiety before and after finishing the radiography procedures. A structured questionnaire will be used to evaluate the satisfaction and experience regarding using a Virtual reality device. The pulse rate, blood pressure, and oxygen saturation will be measured for physiological assessment at three timepoints (pre-procedure, during procedure and post-procedure).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Periapical radiograph will be taken without VR

Other

In the comparison group no intervention will be used. Standard periapical radiographs will be taken for endodontic diagnostic procedure.

Periapical radiograph will be taken with VR

Device

The VR headset will be loaded with a short, animated movie, which will be shown to each participant in the experimental group two minutes during the standard periapical radiographs taking procedure.

Primary outcomes

  1. Severity of gagging

    Time frame: 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.

Secondary outcomes

  1. Dental anxiety

    Time frame: Immediately before and immediately after the radiographic procedure (Day 1).

    Dental anxiety will be assessed using the 5-item Modified Dental Anxiety Scale (MDAS). Each item is scored from 1 (not anxious) to 5 (extremely anxious), with a total score range of 5-25; higher scores indicate greater anxiety.

  2. Physiological response (pulse rate, blood pressure, and oxygen saturation)

    Time frame: Before, during, and after the radiographic procedure (Day 1).

    Physiological parameters, including pulse rate (beats per minute), blood pressure (mmHg), and oxygen saturation (%), will be recorded to evaluate physiologic changes during virtual reality distraction.

  3. Patient preferences, experiences, and satisfaction

    Time frame: Immediately after X-ray film placement (post-procedural, Day 1).

    A structured questionnaire using a 5-point Likert scale will be used to evaluate patients' preferences, experiences, and satisfaction with the virtual reality device during intraoral radiography.

    Each item is scored from 1 (very dissatisfied / strongly disagree) to 5 (very satisfied / strongly agree); higher scores indicate a more favorable experience.

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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