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

April 29, 2026 updated by: The University of Texas Health Science Center at San Antonio

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Nida-e-Haque M Mahmud, DDS, BDS
  • Phone Number: (210) 567-3559
  • Email: mahmud@uthscsa.edu

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • SADE
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect of SADE on Heart Rate
Time Frame: Baseline to approximately 50 minutes (after dental appointment)
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
Time Frame: Baseline to approximately 50 minutes (after dental appointment)
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
Time Frame: Baseline to approximately 50 minutes (after dental appointment)
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
Time Frame: Baseline to approximately 50 minutes (after dental appointment)
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)
Venham's Clinical Anxiety Scale
Time Frame: Baseline to approximately 50 minutes (after dental appointment)
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)
Ohio State University Behavior Rating Scale
Time Frame: Baseline to approximately 50 minutes (after dental appointment)
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)
Wong Bakers Visual FACES Scale Modified
Time Frame: Visit 1 Day 1 to Visit 2 (May occur Day 90-120)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center at San Antonio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nida-e-Haque Mahmud, DDS, BDS, The University of Texas Health Science Center at San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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