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Clinical Trials in Italy / NCT07503249
Starting soon Not applicable

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

NCT07503249 · tracked via the Priya Life Science Italy tracker
Sponsor
Oasi Research Institute-IRCCS
Phase
Not applicable
Started
2026-04-20
Last updated
2026-04-07

Condition(s) studied

Borderline Intellectual Functioning (BIF)

Investigational drug(s) / intervention(s)

immersive VR software delivered through Meta Quest 3® headset during dental procedureSensory adapted dentist environment

immersive VR software delivered through Meta Quest 3® headset during dental procedure: immersive VR software delivered through Meta Quest 3® headset during dental procedure

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

Study summary

A randomized clinical trial was conducted with 100 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 (50 per group). The primary outcome was treatment success, defined as completing a dental restoration under local anesthesia within 30 minutes.

Eligibility

Sex
ALL
Min age
11 Years
Max age
13 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Treatment success — 30 minutes
    Completion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)

Trial sites (1)

FacilityCityRegionStatus
Oasi Research Institute Troina EN

More Oasi Research Institute-IRCCS trials in Italy

Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability: A Randomized Controlled Trial Starting soon
Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability Starting soon
Comparison of Orthodontic Aligner Treatment Protocols Managed Through Remote Monitoring Versus In-Person Care Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07503249 on ClinicalTrials.gov ↗ ← All trials in Italy