Not Yet RecruitingNot Applicable

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

Italy100 participantsStarted 2026-04-20

Plain-language 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.

Who can participate

Age range11 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Treatment success

Timeframe: 30 minutes

Trial details

NCT IDNCT07503249

SponsorOasi Research Institute-IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-05

Contact for this trial

Antonio Fallea

3381113255 afallea@oasi.en.it

View on ClinicalTrials.gov More Borderline Intellectual Functioning (BIF) trials