Print

Lay Description


This clinical trial examines the efficacy of a Sensory-Adapted Dental Environment (SADE) in reducing anxiety and improving behavioral outcomes in children with sensory processing disorders during routine dental visits. By modifying the dental setting to accommodate sensory sensitivities—such as using dim lighting, noise-canceling headphones, and non-threatening dental tools—the study aims to create a more comfortable dental experience for these children. This research could potentially inform broader pediatric dentistry practices, making dental care more accessible and less distressing for children with sensory sensitivities.

Category

  • Behaviors and Mental Disorders
  • Mouth and Tooth
  • Child Health
IRB Number
STUDY00000573
NCT Number
NCT06411808

Eligibility

Eligible Ages
5-17 years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Arm Groups

Study Contact


Noorpreet Kaur
210-450-7054
kaurn1@uthscsa.edu

Principal Investigator
Nida-E-haque Mahmud

Principal Investigator
Nida-E-haque Mahmud