NCT07503262

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

15 days

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

Mild Intellectual Disability

Outcome Measures

Primary Outcomes (1)

  • Pain perception

    Pain perception measured using the FLACC scale

    25 minutes of dental hygiene treatment

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL
Device: Virtual reality based distraction

No distractor

ACTIVE COMPARATOR
Device: No distractor

Interventions

Virtual reality based distractionDEVICE

Dental polishing performed in individuals with VR device.

Virtual Reality Distraction
No distractorDEVICE

Dental treatment performed in inviduals without distractor device

No distractor

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Moderate dental anxiety
  • Mild intellectual disability
  • Age between 5 and 7 years

You may not qualify if:

  • \- Severe/low dental anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oasi Research Institute

Troina, EN, 94018, Italy

Location

Related Publications (1)

  • 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: 40869621BACKGROUND

Central Study Contacts

Antonio Fallea

CONTACT

3381113255afallea@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)