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

NCT ID: NCT07261670

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-09-30

Brief Summary

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A randomized clinical trial was conducted with 98 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 (49 per group). The primary outcome was treatment success, defined as completing a dental restoration under local anesthesia within 30 minutes.

Detailed Description

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Conditions

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Borderline Intellectual Functioning (BIF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sensory adapted dentist environment Control

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

Group Type ACTIVE_COMPARATOR

Sensory adapted dentist environment

Intervention Type 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

Virtual Reality Distraction

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

Group Type EXPERIMENTAL

Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure

Intervention Type DEVICE

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

Interventions

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Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

11 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oasi Research Institute-IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Ass. Oasi Maria SS

Troina, EN, Italy

Site Status

Countries

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Italy

Other Identifiers

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RC-2794677_

Identifier Type: -

Identifier Source: org_study_id

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