NCT07503249

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Oasi Research Institute-IRCCS · Academic / Other
• Sex: All
• Age: 11 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Borderline Intellectual Functioning (BIF)

Interventions

Type	Name	Description
DEVICE	immersive VR software delivered through Meta Quest 3® headset during dental procedure	immersive VR software delivered through Meta Quest 3® headset during dental procedure
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

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-05-05
• Completion: 2026-05-10
• First posted: 2026-03-31
• Last updated: 2026-04-07

Locations

1 site across 1 country: Italy