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

NCT07503249 | Not Yet Recruiting DMC

• 1 other identifier: RC-2794677 (Dentistry)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Intellectual Functioning (BIF); Moderate Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• Treatment success

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

  30 minutes

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

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

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

Sensory adapted dentist environment Control

ACTIVE COMPARATOR

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

Interventions

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

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

Virtual Reality Distraction

Sensory adapted dentist environment DEVICE

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

Sensory adapted dentist environment Control

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Absence of dental anxiety (DAS score = 4)
• The presence of mild anxiety (DAS score = 5-8)
• High or severe anxiety (DAS score ≥ 13)

Sponsors & Collaborators

• Oasi Research Institute-IRCCS: lead

Study Sites (1)

Oasi Research Institute

Troina, EN, 94018, Italy

Location

Related Publications (1)

• Fallea A, Zuccarello R, Roccella M, Quatrosi G, Donadio S, Vetri L, Cali F. Sensory-Adapted Dental Environment for the Treatment of Patients with Autism Spectrum Disorder. Children (Basel). 2022 Mar 10;9(3):393. doi: 10.3390/children9030393.

  PMID: 35327765 BACKGROUND

Central Study Contacts

Antonio Fallea

CONTACT

3381113255; afallea@oasi.en.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: April 20, 2026
• Primary Completion: May 5, 2026
• Study Completion: May 10, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

IT (1)