Virtual Reality Distraction During Restorative Dental Treatment

NCT07738718 | Recruiting DMC

• 1 other identifier: 26-63-13
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.

Conditions

Dental Anxiety; Pain

Keywords

Virtual Reality; Local Anesthesia; Restorative Dentistry; Pain Perception; Patient Experience; Dental Treatment; Split-Mouth Trial; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.

• Pain Perception

  Pain intensity will be measured using a 0-10 cm Visual Analog Scale (VAS) following local anaesthesia administration and will be compared between the virtual reality and conventional treatment conditions. Higher scores indicate more pain.

  Immediately after local anaesthesia administration during each treatment session on day 1.

Secondary Outcomes (10)

• Pulse rate

  Before the dental procedure, immediately after local anaesthesia administration, and immediately after completion of the dental procedure on Day 1.

• Systolic blood pressure

  Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.

• Diastolic blood pressure

  Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.

• Oxygen saturation

  Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.

• Patient comfort

  Immediately after completion of each treatment session (Day 1).

Study Arms (2)

Group 1. Virtual Reality Distraction

EXPERIMENTAL

Participants will receive local anesthesia and restorative dental treatment while using an immersive virtual reality headset as a distraction intervention.

Device: Virtual Reality Headset

Group 2. Conventional Treatment

ACTIVE COMPARATOR

Participants will receive local anesthesia and restorative dental treatment without virtual reality distraction according to the standard clinical procedure.

Other: Standard Dental Treatment

Interventions

Virtual Reality Headset DEVICE

Participants will wear an immersive virtual reality headset during local anesthesia administration and restorative dental treatment. The virtual reality intervention is used as a non-pharmacological distraction technique to reduce pain perception and anxiety and to improve the overall patient experience during dental treatment.

Group 1. Virtual Reality Distraction

Standard Dental Treatment OTHER

Participants will receive conventional local anesthesia and restorative dental treatment without virtual reality distraction. All clinical procedures will be performed according to the standard treatment protocol and will serve as the control condition for comparison with the virtual reality intervention.

Group 2. Conventional Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years) requiring bilateral Class I restorative dental treatment.
• Presence of bilateral Class I carious lesions extending to the inner one-third of dentin (D3) with symptoms of reversible pulpitis.
• Willing and able to provide written informed consent.
• Willing to participate in the study and comply with study procedures.

You may not qualify if:

• Children (\<18 years).
• American Society of Anesthesiologists (ASA) Physical Status Class III or higher.
• Deep Class I carious lesions with pulpal involvement.
• Mentally or medically compromised patients.
• Patients presenting with acute dental pain, such as acute pulpitis.

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Professor Muhammad Zubair Ahmad

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

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the intervention, participants and the treating dentist can not be blinded to the use of virtual reality. Outcomes will be collected following each treatment session.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 31, 2026
• Study Start: August 25, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)