Clinical trial NCT06411808: Evaluating Sensory-Adapted Dental Care in Children With Sensory Processing Disorders
Official title: The Impact of Sensory-Adapted Dental Environment on Anxiety and Behavior in Children With Sensory Processing Disorders: A Crossover Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sensory Processing Disorder
Keywords: sensory processing disorders
pediatric dentistry
dental anxiety
behavioral outcomes
sensory adaptation
crossover randomized controlled trial
sensory modulation disorder
sensory over-responsivity
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive dental care in both a standard and a sensory-adapted dental environment in a randomized order to compare effects on anxiety and behavior.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The study is a crossover randomized controlled trial designed to assess the impact of a Sensory-Adapted Dental Environment (SADE) on children with sensory processing disorders, focusing on both physiological and behavioral responses. Participants will undergo two dental cleaning visits; one in a standard dental environment and one in a sensory-adapted setting. Each visit will be spaced three to four months apart to monitor short-term effects and behaviors. The primary outcomes measured will include changes in anxiety levels, as assessed by physiological markers (e.g., heart rate) and behavioral scales (e.g., modified dental anxiety scale). Secondary outcomes will evaluate the overall acceptance of the sensory-adapted environment by children and their caregivers. This study seeks to demonstrate that tailored environmental modifications can significantly improve the dental care experience, potentially leading to enhanced long-term dental health and reduced care avoidance among children with sensory processing disorders. The trial will also gather qualitative feedback from participants and their parents to better understand individual experiences and refine future adaptations in pediatric dental practices.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of SADE on Heart Rate
timeFrame: Baseline to approximately 50 minutes (after dental appointment)
measure: Effect of SADE on Oxygen Saturation
timeFrame: Baseline to approximately 50 minutes (after dental appointment)
measure: Effect of SADE on Systolic and Diastolic Blood Pressure
timeFrame: Baseline to approximately 50 minutes (after dental appointment)
measure: Frankl Behavior Rating Scale Change
timeFrame: Baseline to approximately 50 minutes (after dental appointment)
measure: Ohio State University Behavior Rating Scale
timeFrame: Baseline to approximately 50 minutes (after dental appointment)
measure: Venham's Clinical Anxiety Scale
timeFrame: Baseline to approximately 50 minutes (after dental appointment)
measure: Wong Bakers Visual FACES Scale Modified
timeFrame: Visit 1 Day 1 to Visit 2 (May occur Day 90-120)
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Nida-e-Haque Mahmud, DDS, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cermak SA, Stein Duker LI, Williams ME, Dawson ME, Lane CJ, Polido JC. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study. J Autism Dev Disord. 2015 Sep;45(9):2876-88. doi: 10.1007/s10803-015-2450-5.
citation: 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.
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citation: Cermak SA, Stein Duker LI, Williams ME, Lane CJ, Dawson ME, Borreson AE, Polido JC. Feasibility of a sensory-adapted dental environment for children with autism. Am J Occup Ther. 2015 May-Jun;69(3):6903220020p1-10. doi: 10.5014/ajot.2015.013714.
citation: P BJ. Dental subscale of children's fear survey schedule and dental caries prevalence. Eur J Dent. 2013 Apr;7(2):181-185. doi: 10.4103/1305-7456.110166.
citation: Kim G, Carrico C, Ivey C, Wunsch PB. Impact of sensory adapted dental environment on children with developmental disabilities. Spec Care Dentist. 2019 Mar;39(2):180-187. doi: 10.1111/scd.12360. Epub 2019 Feb 6.
citation: Ismail AF, Tengku Azmi TMA, Malek WMSWA, Mallineni SK. The effect of multisensory-adapted dental environment on children's behavior toward dental treatment: A systematic review. J Indian Soc Pedod Prev Dent. 2021 Jan-Mar;39(1):2-8. doi: 10.4103/jisppd.jisppd_36_21.