Phase
Condition
Autism Spectrum Disorder (Asd)
Autism
Treatment
Sensory-Adapted Dental Environment
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability of subject (or Legally Authorized Representative (LAR)) to understand andthe willingness to sign a written informed consent document.
For children, informed assent and parental informed consent to participate in thestudy.
Males and females; Age <5-17 years>
Self-reported or documented diagnosis of sensory processing disorder (SPD), sensorymodulation disorder (SMD), or sensory over-responsivity (SOR) based on medicalrecords 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 atypicalneurodevelopmental conditions where specific sensory challenges are present.
A score above the threshold on the Sensory Profile-2, which indicates significantsensory processing issues.
A history of at least one previous dental cleaning, to ensure familiarity with thedental care process.
Willingness and ability to adhere to the study intervention regimen, includingattending two dental sessions in different environmental settings (RDE and SADE).
Ability to attend intervention sessions at the designated site, UT Health School ofDentistry.
Access to transportation or necessary resources for participating in the studysessions at the UT Health School of Dentistry.
Not currently undergoing orthodontic braces treatment or using anticholinergicmedication, as per the exclusion criteria.
Exclusion
Exclusion Criteria:
Significant developmental disabilities or medical conditions that preclude the safeconduct of dental procedures or the ability to consent, even with a LegallyAuthorized Representative (LAR), such as uncontrolled epilepsy or severe behavioraldisorders that could lead to self-harm or harm to staff within a dental setting.
Complex dental needs that require specialized procedures or surgeries not providedwithin the study's dental care setting, such as advanced orthodontic work or oralsurgery, which might interfere with the study's assessments or outcomes.
Previous traumatic dental experiences resulting in extreme dental care avoidance, asthis could confound the effects of the SADE versus RDE environments.
Current or scheduled orthodontic braces treatment during the study period, as bracesmay affect the child's sensory experience and response to the dental environment.
Use of anticholinergic medication, due to their potential to alter physiologicalmeasures 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 theparticipant's safety or may affect the study outcomes.
Study Design
Study Description
Connect with a study center
UT Health San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
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