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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-28

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sensory Processing Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Sensory-Adapted Dental Environment

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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SADE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No