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Dental makeover eases anxiety for kids with sensory issues

NCT ID NCT06411808

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a specially adapted dental environment for children with sensory processing disorders. The setting used dim lighting, quiet sounds, and non-scary tools to reduce anxiety. Twenty children participated, and researchers measured their heart rate, blood pressure, and behavior during dental visits. The goal was to see if these simple changes could make dental care less stressful for kids with sensory sensitivities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sensory-Adapted Dental Environment (SADE) - a modified dental setting with dim lighting, noise-canceling headphones, and non-threatening tools
What this could lead to
If effective, this approach could make dental visits less stressful and more accessible for children with sensory processing disorders.
What could go wrong
This is a small, completed trial with only 20 participants, so results may not apply to all children. The intervention is behavioral and may not work for every child.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jun 2024

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document. * For children, informed assent and parental informed consent to participate in the study. * Males and females; Age \<5-17 years\> * Self-reported or documented diagnosis of sensory processing disorder (SPD), sensory modulation disorder (SMD), or sensory over-responsivity (SOR) based on medical records or occupational therapy evaluation. Diagnosis codes per ICD-10 may include, but are not limited to, F88 and F89 for SPD, as these are often used for atypical neurodevelopmental conditions where specific sensory challenges are present. * A score above the threshold on the Sensory Profile-2, which indicates significant sensory processing issues. * A history of at least one previous dental cleaning, to ensure familiarity with the dental care process. * Willingness and ability to adhere to the study intervention regimen, including attending two dental sessions in different environmental settings (RDE and SADE). * Ability to attend intervention sessions at the designated site, UT Health School of Dentistry. * Access to transportation or necessary resources for participating in the study sessions at the UT Health School of Dentistry. * Not currently undergoing orthodontic braces treatment or using anticholinergic medication, as per the exclusion criteria. Exclusion Criteria: * Significant developmental disabilities or medical conditions that preclude the safe conduct of dental procedures or the ability to consent, even with a Legally Authorized Representative (LAR), such as uncontrolled epilepsy or severe behavioral disorders that could lead to self-harm or harm to staff within a dental setting. * Complex dental needs that require specialized procedures or surgeries not provided within the study's dental care setting, such as advanced orthodontic work or oral surgery, which might interfere with the study's assessments or outcomes. * Previous traumatic dental experiences resulting in extreme dental care avoidance, as this could confound the effects of the SADE versus RDE environments. * Current or scheduled orthodontic braces treatment during the study period, as braces may affect the child's sensory experience and response to the dental environment. * Use of anticholinergic medication, due to their potential to alter physiological measures of stress and anxiety, which are key outcomes for this study. * Any condition that, in the opinion of the investigators, may pose a risk to the participant's safety or may affect the study outcomes.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

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