Not yet recruiting NCT07473479
Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability: A Randomized Controlled Trial
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: Professional oral hygiene session, No distractor.
- Who it may be relevant to
- Registry conditions: Mild Intellectual Disability. Basic parameters: 5 years — 7 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 →
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Overview
The objective of this study was to evaluate whether the use of a virtual reality (VR) distractor reduces perceived pain during professional oral hygiene sessions in children with mild ID.
Interventions
- Device Professional oral hygiene session
Dental polishing performed in individuals with VR device - Device No distractor
Dental treatment performed in inviduals without distractor device
Primary outcome measures
- Pain perception [Time frame: 25 minutes of dental hygiene treatment]
Eligibility criteria
Inclusion criteria
- Moderate dental anxiety
- Mild intellectual disability
- Age between 5 and 7 years
Exclusion criteria
- Severe/low dental anxiety
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 IRCCS Research Institute — Troina
Publications
- Fallea A, Costanza C, L'Episcopo S, Bartolone M, Rundo F, Smirni D, Roccella M, Elia M, Ferri R, Vetri L. Virtual Reality-Based Versus Traditional Teaching Approaches in the Oral Hygiene Education of Children with Autism Spectrum Disorder. J Clin Med. 2025 Aug 15;14(16):5795. doi: 10.3390/jcm14165795. PMID 40869621
Identifiers
NCT: NCT07473479 · RC-2794677 (medicina)