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

NCT06411808 | Completed DMC

• 1 other identifier: STUDY00000573
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline to approximately 50 minutes (after dental appointment)

• 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.

  Baseline to approximately 50 minutes (after dental appointment)

• 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.

  Baseline to approximately 50 minutes (after dental appointment)

• 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.

  Baseline to approximately 50 minutes (after dental appointment)

• 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.

  Baseline to approximately 50 minutes (after dental appointment)

• 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.

  Baseline to approximately 50 minutes (after dental appointment)

• 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.

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

Study Arms (2)

SADE Group: Sensory-Adapted Dental Environment

EXPERIMENTAL

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

Control Group: Regular Dental Environment

NO INTERVENTION

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

Interventions

Sensory-Adapted Dental Environment BEHAVIORAL

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

SADE Group: Sensory-Adapted Dental Environment

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (8)

• 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.

  PMID: 25931290 BACKGROUND

• 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.

  PMID: 35327765 BACKGROUND

• 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.

  PMID: 37266941 BACKGROUND

• 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.

  PMID: 36360634 BACKGROUND

• 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.

  PMID: 25871593 BACKGROUND

• 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.

  PMID: 24883023 BACKGROUND

• 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.

  PMID: 30729554 BACKGROUND

• 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.

  PMID: 33885380 BACKGROUND

Study Officials

• Nida-e-Haque Mahmud, DDS, BDS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and study personnel involved in the delivery and assessment of the treatment outcomes are blinded to the phase order to maintain the integrity of the study results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 13, 2024
• Study Start: June 28, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documentation will become available starting 6 months after the publication of the main results and remain accessible for a period of 5 years. This allows sufficient time for the research community to propose, prepare, and conduct secondary analyses.
• Access Criteria: Access to the shared IPD will be granted to researchers who provide a methodologically sound proposal. Applications for access will be reviewed by an independent review committee appointed by the University of Texas Health Science Center. Criteria for evaluation will include the scientific merit of the research proposal, the research team's expertise, and the potential to contribute to scientific understanding or clinical improvement.

Locations

US (1)