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

Oasi Research Institute-IRCCS

Status: Completed

Conditions: Borderline Intellectual Functioning (BIF)

Treatments: Device: Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure; Device: Sensory adapted dentist environment

Study type: Interventional

Funder types: Other

Identifiers

NCT07261670

RC-2794677_

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 11 to 13 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Virtual Reality Distraction

Experimental group

Description:

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

Treatment:

Device: Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure

Sensory adapted dentist environment Control

Active Comparator group

Description:

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:

Device: Sensory adapted dentist environment