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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07261670
Acronym
VR-SADE
Enrollment
98
Registered
2025-12-03
Start date
2025-06-01
Completion date
2025-09-30
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Intellectual Functioning (BIF)

Brief summary

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.

Interventions

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

Sponsors

Oasi Research Institute-IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 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)

Design outcomes

Primary

MeasureTime frameDescription
Treatment successDuration of procedureCompletion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026