- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236138
Controlling Gag Reflex During Endodontic Diagnostic Radiography
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Al-Qassim Region
-
Ar Rass, Al-Qassim Region, Saudi Arabia, 58883
- Professor Muhammad Zubair Ahmad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
In the comparison group no intervention will be used.
Standard periapical radiographs will be taken for endodontic diagnostic procedure.
|
|
Experimental: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (pre-procedure) and periprocedural (during X-ray film placement) on Day 1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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).
|
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.
|
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).
|
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. |
Immediately after X-ray film placement (post-procedural, Day 1).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-14-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Periapical radiograph will be taken without VR
-
Hillel Yaffe Medical CenterUnknownBody Mass IndexIsrael
-
Imperial College LondonAsthma UKWithdrawnHealthy Volunteers | Chronic Obstructive Airway DiseaseUnited Kingdom
-
Medical University of GrazTerminatedAnti-SARS-CoV-2 Antibody ResponseAustria
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Poitiers University HospitalNot yet recruiting
-
Maastricht Radiation OncologyMaastricht University Medical Center; Maastricht UniversityRecruiting
-
KU LeuvenRecruiting
-
Cukurova UniversityCompletedOptic Papilla EdemaTurkey
-
Centre Hospitalier Universitaire DijonCompletedLocalized Non-Resectable Adult Hepatocellular CarcinomaFrance
-
Institut Claudius RegaudRecruiting