GaggingNCT07236138
Controlling Gag Reflex During Endodontic Diagnostic Radiography
A study testing Periapical radiograph will be taken without VR and Periapical radiograph will be taken with VR in people with Gagging and Satisfaction, Patient, run by Qassim University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gagging, Satisfaction, Patient, Endodontic Disease
- What is being tested?
- Periapical radiograph will be taken without VR and Periapical radiograph will be taken with VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2024to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Professor Muhammad Zubair Ahmad
Ar Rass, Al-Qassim Region, 58883
About this study
Official 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
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Gagging, Satisfaction, Patient, Endodontic Disease, Anxiety, Xray Complication
- Being tested
- Periapical radiograph will be taken without VR, Periapical radiograph will be taken with VR
- Keywords
- distraction, endodontic diagnosis, gag reflex, periapical radiograph, virtual reality
- Medical subject headings
- Gagging, Patient Satisfaction, Dental Pulp Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periapical radiograph will be taken without VROther
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 VRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Periapical radiograph will be taken with VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-procedure) and periprocedural (during X-ray film placement) on Day 1.
Secondary outcomes (3)
Dental anxiety
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.
Measured: Immediately before and immediately after the radiographic procedure (Day 1).
Physiological response (pulse rate, blood pressure, and oxygen saturation)
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.
Measured: Before, during, and after the radiographic procedure (Day 1).
Patient preferences, experiences, and satisfaction
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.
Measured: Immediately after X-ray film placement (post-procedural, Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Sep 2024
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaggingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Zubair Ahmad, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236138
- Sponsor's protocol ID
- 24-14-11
- Status last verified
- Jan 2026
- First submitted
- 23 Apr 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07236138
- Acronym / sponsor ID
- 24-14-11
- Conditions
- Gagging, Satisfaction, Patient, Endodontic Disease, Anxiety, Xray Complication
- Keywords
- distraction, endodontic diagnosis, gag reflex, periapical radiograph, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1. Periapical radiograph without virtual reality (VR) distraction | Other | Other: Periapical radiograph will be taken without VRIn 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. |
| Group 2. Periapical radiograph with virtual reality (VR) distraction | Experimental | Device: Periapical radiograph will be taken with VRIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periapical radiograph will be taken without VRIn the comparison group no intervention will be used. Standard periapical radiographs will be taken for endodontic diagnostic procedure. | Other | Group 1. Periapical radiograph without virtual reality (VR) distraction |
| Periapical radiograph will be taken with VRThe 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. | Device | Group 2. Periapical radiograph with virtual reality (VR) distraction |
Primary outcome
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.
3 secondary outcomes
Dental anxiety
Time frame: Immediately before and immediately after the radiographic procedure (Day 1).
Physiological response (pulse rate, blood pressure, and oxygen saturation)
Time frame: Before, during, and after the radiographic procedure (Day 1).
Patient preferences, experiences, and satisfaction
Time frame: Immediately after X-ray film placement (post-procedural, Day 1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periapical radiograph will be taken without VR and Periapical radiograph will be taken with VR in people with Gagging and Satisfaction, Patient, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of gagging (time frame: Baseline (pre-procedure) and periprocedural (during X-ray film placement) on Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.