A Comparative Study of Virtual Reality and Sensory-Adapted Dental Environments for Dental Anxiety Reduction in Individuals With BIF (VR-SADE)

November 21, 2025 updated by: Oasi Research Institute-IRCCS

A Comparative Study of Virtual Reality and Sensory-Adapted Dental Environments for Dental Anxiety Reduction in Individuals With Borderline Intellectual Functioning

A randomized clinical trial was conducted with 98 participants with borderline intellectual functioning (BIF) and moderate dental anxiety (DAS: 9-12). Participants were assigned in a 1:1 ratio to either the Virtual reality (VR) or sensory adapted dentist environment (SADE) group (49 per group). The primary outcome was treatment success, defined as completing a dental restoration under local anesthesia within 30 minutes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • EN
      • Troina, EN, Italy, 94018
        • IRCCS Ass. Oasi Maria SS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age of participants between 10 and 13 years
  • Diagnosis of Borderline Intellectual Func-tioning (BIF) confirmed by experienced neuropsychiatrists according to DSM-5 criteria
  • Moderate dental anxiety, defined by a DAS score between 9 and 12
  • Presence of at least one tooth with a Class I carious lesion requiring restorative treatment

Exclusion Criteria:

  • absence of dental anxiety (DAS score = 4)
  • the presence of mild anxiety (DAS score = 5-8)
  • high or severe anxiety (DAS score ≥ 13)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Distraction
immersive VR software delivered through Meta Quest 3® headset during dental procedure
Device: Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure
immersive VR software delivered through Meta Quest 3® headset during dental procedure
Active Comparator: Sensory adapted dentist environment Control

Sensory adapted dentist environment designed to reduce sensory stimuli with:

  • soft and dim lighting
  • a screen projecting familiar movies, cartoons, or videos previously provided by the family
  • a dental turbine handpiece covered with a sponge layer to minimize noise
Device: Sensory adapted dentist environment
Sensory adapted dentist environment designed to reduce sensory stimuli with: - soft and dim lighting - a screen projecting familiar movies, cartoons, or videos previously provided by the family - a dental turbine handpiece covered with a sponge layer to minimize noise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: Duration of procedure
Completion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)
Duration of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oasi Research Institute-IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • RC-2794677_

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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