An interventional study of Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure and Sensory adapted dentist environment in Borderline Intellectual Functioning (BIF), sponsored by Oasi Research Institute-IRCCS. Completed at 1 site in Italy. Open to participants aged 11 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Oasi Research Institute-IRCCS · Not applicable, Interventional, and Treatment
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.
Oasi Research Institute-IRCCS is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
immersive VR software delivered through Meta Quest 3® headset during dental procedure
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
Treatment success
Completion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)
Time frame: Duration of procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Oasi Research Institute-IRCCS