Borderline Intellectual Functioning (BIF)NCT07503249
A Comparative Study of Virtual Reality and Sensory-Adapted Dental Environments for Dental Anxiety Reduction in Individuals With Borderline Intellectual Functioning
A study testing immersive VR software delivered through Meta Quest 3® headset during dental procedure and Sensory adapted dentist environment in people with Borderline Intellectual Functioning (BIF), run by Oasi Research Institute-IRCCS at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- Borderline Intellectual Functioning (BIF)
- What is being tested?
- immersive VR software delivered through Meta Quest 3® headset during dental procedure and Sensory adapted dentist environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2026to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Absence of dental anxiety (DAS score = 4)
- The presence of mild anxiety (DAS score = 5-8)
- High or severe anxiety (DAS score ≥ 13)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Oasi Research Institute
Troina, EN, 94018
Antonio Fallea, 3381113255, afallea@oasi.en.it
About this study
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.
Read the 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.
- Being tested
- immersive VR software delivered through Meta Quest 3® headset during dental procedure, Sensory adapted dentist environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersive VR software delivered through Meta Quest 3® headset during dental procedureDevice
immersive VR software delivered through Meta Quest 3® headset during dental procedure
Sensory adapted dentist environmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Distraction | Experimental | Immersive VR software delivered through Meta Quest 3® headset during dental procedure Receives: Device: immersive VR software delivered through Meta Quest 3® headset during dental procedure |
| Sensory adapted dentist environment Control | Active comparator | 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 Receives: Device: Sensory adapted dentist environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Completion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion5 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Intellectual Functioning (BIF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oasi Research Institute-IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503249
- Sponsor's protocol ID
- RC-2794677 (Dentistry)
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35327765
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Virtual Reality and Sensory-Adapted Dental Environments for Dental Anxiety Reduction in Individuals With Borderline Intellectual Functioning
- ClinicalTrials.gov ID
- NCT07503249
- Acronym / sponsor ID
- RC-2794677 (Dentistry)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oasi Research Institute-IRCCSUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Distraction | Experimental | Device: immersive VR software delivered through Meta Quest 3® headset during dental procedureImmersive VR software delivered through Meta Quest 3® headset during dental procedure |
| Sensory adapted dentist environment Control | Active comparator | Device: Sensory adapted dentist environmentSensory 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 |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Absence of dental anxiety (DAS score = 4)
- The presence of mild anxiety (DAS score = 5-8)
- High or severe anxiety (DAS score ≥ 13)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immersive VR software delivered through Meta Quest 3® headset during dental procedureimmersive VR software delivered through Meta Quest 3® headset during dental procedure | Device | Virtual Reality Distraction |
| Sensory adapted dentist environmentSensory 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 | Device | Sensory adapted dentist environment Control |
Primary outcome
Treatment success
Time frame: 30 minutes
Completion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 35327765Fallea 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immersive VR software delivered through Meta Quest 3® headset during dental procedure and Sensory adapted dentist environment in people with Borderline Intellectual Functioning (BIF), run by Oasi Research Institute-IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Fallea (3381113255, afallea@oasi.en.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.