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OpenTrials
Completed

NCT Number: NCT07261670

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

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.

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Key information

Conditions

Borderline Intellectual Functioning (BIF)

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ass. Oasi Maria SS

Troina, EN, 94018, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual Reality Distraction - 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

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

Primary outcomes

  1. Treatment success

    Time frame: Duration of procedure

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

Sponsors and collaborators

Lead sponsor

Oasi Research Institute-IRCCS

Other

Registry information

Official study title

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

Acronym: VR-SADE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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