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

Sensory Processing Disorder Clinical Trial

Official title:

The Impact of Sensory-Adapted Dental Environment on Anxiety and Behavior in Children With Sensory Processing Disorders: A Crossover Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411808
• Other study ID #: STUDY00000573
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Nida-e-Haque M Mahmud, DDS, BDS
• Phone: (210) 567-3559
• Email: mahmud[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 31, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sensory Processing Disorder

Intervention

Behavioral:
• Sensory-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.

Locations

Country	Name	City	State
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Wong Bakers Facial Visual Analog Scale	This Wong Bakers Facial Visual Analog scale rates the participants' pain using a visual depiction of a face from smiling (score of 0 - no hurt) to sad (score of 10 - hurts worst). Score will be reported as a change from baseline to the end of the dental visit.	Baseline to approximately 50 minutes (after dental appointment)
Primary	Ohio 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)
Primary	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)