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

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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07503249
Enrollment
100
Registered
2026-03-31
Start date
2026-04-20
Completion date
2026-05-10
Last updated
2026-04-07

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 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.

Interventions

DEVICEimmersive 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 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 success30 minutesCompletion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)

Countries

Italy

Contacts

CONTACTAntonio Fallea
afallea@oasi.en.it3381113255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026