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CompletedNCT06411808Updated May 6, 2026

Evaluating Sensory-Adapted Dental Care in Children With Sensory Processing Disorders

An interventional study of Sensory-Adapted Dental Environment in Sensory Processing Disorder, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
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

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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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    SADE Group: Sensory-Adapted Dental Environment

    Participants in this arm will experience dental care in a Sensory-Adapted Dental Environment. Modifications such as dimmed lighting, noise-canceling headphones, and specialized dental tools are used to minimize sensory overload and enhance comfort during dental procedures.

    Behavioral: Sensory-Adapted Dental Environment

  • No intervention
    Control Group: Regular Dental Environment

    Participants in this arm will receive dental care in a Regular Dental Environment without sensory adaptations, representing standard dental care settings.

Interventions

  • BehavioralSensory-Adapted Dental Environment

    The Sensory-Adapted Dental Environment (SADE) involves altering the dental setting to reduce sensory stimuli that can cause discomfort or anxiety in children with sensory processing disorders. This includes the use of controlled lighting, ambient sounds, and non-threatening tools to create a calming atmosphere conducive to positive dental experiences.

    Also known as: SADE

06

What researchers measure

Primary outcomes

  1. Effect of SADE on Heart Rate

    This measure evaluates the impact of the Sensory-Adapted Dental Environment (SADE) on physiological indicators of anxiety, specifically heart rate change.

    Time frame: Baseline to approximately 50 minutes (after dental appointment)

  2. Effect of SADE on Oxygen Saturation

    This measure evaluates the impact of the Sensory-Adapted Dental Environment (SADE) on physiological indicators of anxiety, specifically oxygen saturation change.

    Time frame: Baseline to approximately 50 minutes (after dental appointment)

  3. Effect of SADE on Systolic and Diastolic Blood Pressure

    This measure evaluates the impact of the Sensory-Adapted Dental Environment (SADE) on physiological indicators of anxiety, with change in systolic or diastolic blood pressure.

    Time frame: Baseline to approximately 50 minutes (after dental appointment)

  4. Frankl Behavior Rating Scale Change

    A change in score on the Frankl behavioral rating scale. This is a scored as a single rating of behavior between 1 and 4 with a higher score indicating a more positive attitude.

    Time frame: Baseline to approximately 50 minutes (after dental appointment)

  5. Ohio State University Behavior Rating Scale

    This scale rates the participants' behavior. A change in score on the behavioral rating scale. This is a scored as a single rating of behavior between 1 and 4 with a lower score indicating a more positive attitude.

    Time frame: Baseline to approximately 50 minutes (after dental appointment)

  6. Venham's Clinical Anxiety Scale

    A scale used to measure the change in clinical anxiety of participants will be a single item scored from 0-3, where a higher score indicates more anxiety and protest from the participant.

    Time frame: Baseline to approximately 50 minutes (after dental appointment)

  7. Wong Bakers Visual FACES Scale Modified

    A modification of Wong-Baker scale designed to understand the child's anxiety on the same scale and faces pattern, pre-visit and post-visit.

    Time frame: Visit 1 Day 1 to Visit 2 (May occur Day 90-120)

07

Study locations

1 site
  • UT Health San Antonio
    San Antonio, Texas 78229, United States
08

References and documents

Publications

  • 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. PubMed 25931290 ↗
  • 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 ↗
  • Stein Duker LI, Como DH, Jolette C, Vigen C, Gong CL, Williams ME, Polido JC, Florindez-Cox LI, Cermak SA. Sensory Adaptations to Improve Physiological and Behavioral Distress During Dental Visits in Autistic Children: A Randomized Crossover Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316346. doi: 10.1001/jamanetworkopen.2023.16346. PubMed 37266941 ↗
  • Reynolds K, Chandio N, Chimoriya R, Arora A. The Effectiveness of Sensory Adaptive Dental Environments to Reduce Corresponding Negative Behaviours and Psychophysiology Responses in Children and Young People with Intellectual and Developmental Disabilities: A Protocol of a Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Oct 22;19(21):13758. doi: 10.3390/ijerph192113758. PubMed 36360634 ↗
  • 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. PubMed 25871593 ↗
  • 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. PubMed 24883023 ↗
  • 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. PubMed 30729554 ↗
  • 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. PubMed 33885380 ↗

Individual participant data

Plan to share: Yes — We plan to share individual participant data (IPD) that underlie the results reported in this trial after de-identification. Data sets will include all collected IPD encompassing demographic, physiological, behavioral, and self-reported anxiety metrics. The shared data will support further research on sensory processing disorders and dental anxiety, enhancing the reproducibility of our results and enabling secondary analyses by other researchers.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06411808
Lead sponsor
The University of Texas Health Science Center at San Antonio
Responsible party
Sponsor
First posted
May 13, 2024
Start date
Jun 28, 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Last update
May 6, 2026

Study contacts

Nida-e-Haque Mahmud, DDS, BDS
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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