A Comparative Study of Virtual Reality and Sensory-Adapted Dental Environments for Dental Anxiety Reduction in Individuals With Borderline Intellectual Functioning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: immersive VR software delivered through Meta Quest 3® headset during dental procedure, Sensory adapted dentist environment.
- Who it may be relevant to
- Registry conditions: Borderline Intellectual Functioning (BIF). Basic parameters: 11 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device immersive VR software delivered through Meta Quest 3® headset during dental procedure
immersive VR software delivered through Meta Quest 3® headset during dental procedure - Device Sensory adapted dentist environment
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
Primary outcome measures
- Treatment success [Time frame: 30 minutes]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Oasi Research Institute — Troina
Publications
- 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
Identifiers
NCT: NCT07503249 · RC-2794677 (Dentistry)