Controlling Gag Reflex During Endodontic Diagnostic Radiography

NCT07236138 | Completed

• 1 other identifier: 24-14-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gagging; Satisfaction, Patient; Endodontic Disease; Anxiety; Xray Complication

Keywords

distraction; endodontic diagnosis; gag reflex; periapical radiograph; virtual reality

Outcome Measures

Primary Outcomes (1)

• Severity of gagging

  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.

  Baseline (pre-procedure) and periprocedural (during X-ray film placement) on Day 1.

Secondary Outcomes (3)

• 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).

Study Arms (2)

Group 1. Periapical radiograph without virtual reality (VR) distraction

OTHER

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.

Other: Periapical radiograph will be taken without VR

Group 2. Periapical radiograph with virtual reality (VR) distraction

EXPERIMENTAL

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.

Device: Periapical radiograph will be taken with VR

Interventions

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.

Group 2. Periapical radiograph with virtual reality (VR) distraction

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.

Group 1. Periapical radiograph without virtual reality (VR) distraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Professor Muhammad Zubair Ahmad

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

Location

MeSH Terms

Conditions

Gagging; Patient Satisfaction; Dental Pulp Diseases; Anxiety Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Tooth Diseases; Stomatognathic Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized split-mouth (within-subject) parallel design. This was a randomized split-mouth clinical trial in which the intervention and control were allocated to two different sides of the mouth within the same participant. Allocation of the intervention side was determined by randomization. Both interventions were delivered during the same visit, with no time-based sequence or washout period. Each participant therefore served as their own control, receiving both the intervention and control concurrently at different intra-oral sites.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: November 19, 2025
• Study Start: September 1, 2024
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

SA (1)