Sensory-Adapted Dental Care for Sensory Processing Disorder

Overseen By Noorpreet Kaur, DDS, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Anticholinergics

Disqualifiers: Uncontrolled epilepsy, Severe behavioral disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if altering the dental environment can reduce anxiety in children with sensory processing disorders during dental visits. It compares a regular dental setting with a sensory-adapted one that uses dim lighting and noise-canceling headphones to enhance comfort. Children diagnosed with sensory processing issues who have undergone at least one dental cleaning are suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could make dental visits more comfortable for these children.

Will I have to stop taking my current medications?

The trial requires that participants do not use anticholinergic medications, as these can affect the study's outcomes related to stress and anxiety.

What prior data suggests that the Sensory-Adapted Dental Environment is safe for children with sensory processing disorders?

Research has shown that a Sensory-Adapted Dental Environment (SADE) is safe for children, including those with autism. One study found that SADE can improve dental visits without causing harm. This approach uses dim lights, noise-canceling headphones, and special tools to enhance comfort. Another study also demonstrated that SADE is safe and reduces stress during dental visits for children.

These findings suggest that SADE is well-tolerated and does not cause negative side effects. For those considering participation in a trial using this environment, the evidence indicates it is a safe option for improving dental care for children with sensory sensitivities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sensory-Adapted Dental Environment (SADE) because it offers a unique approach to dental care for individuals with Sensory Processing Disorder. Unlike traditional dental settings, which can be overwhelming due to bright lights and loud noises, SADE uses dimmed lighting, noise-canceling headphones, and specialized tools to create a calming atmosphere. This environment aims to reduce sensory overload and increase comfort during dental procedures, which could make dental visits more manageable for those with sensory sensitivities. By addressing the sensory challenges head-on, SADE has the potential to improve the overall dental experience and outcomes for these patients.

What evidence suggests that the Sensory-Adapted Dental Environment is effective for reducing anxiety in children with sensory processing disorders?

Research has shown that a Sensory-Adapted Dental Environment (SADE), which participants in this trial may experience, can reduce anxiety and improve behavior in children with sensory processing issues during dental visits. Studies have found that dim lighting, noise-canceling headphones, and special tools make the dental experience more comfortable for these children. For instance, one study found that these sensory changes significantly reduced distress and discomfort during dental procedures. Additionally, this approach improved dental treatment results for children with autism spectrum disorder (ASD). These findings suggest that SADE might make dental visits less stressful and easier for kids with sensory sensitivities. ^{1 2 4 5 6}

Who Is on the Research Team?

Nida-e-Haque Mahmud, DDS, BDS

Principal Investigator

UT Health San Antonio

Are You a Good Fit for This Trial?

This trial is for children with Sensory Processing Disorder who struggle with the sensory challenges of dental visits. It's designed to help those who may benefit from a dental environment tailored to their needs, making routine care less stressful.

Inclusion Criteria

A score above the threshold on the Sensory Profile-2 indicating significant sensory processing issues

I can understand and am willing to sign the consent form.

I am willing and able to follow the study plan, including attending two special dental sessions.

Exclusion Criteria

Previous traumatic dental experiences resulting in extreme dental care avoidance

Any condition that, in the opinion of the investigators, may pose a risk to the participant's safety or may affect the study outcomes

I need special dental procedures not offered by this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dental Visit 1

Participants undergo a dental cleaning visit in a standard dental environment

1 day

1 visit (in-person)

Dental Visit 2

Participants undergo a dental cleaning visit in a Sensory-Adapted Dental Environment (SADE)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety and behavior after dental visits

3-4 months

What Are the Treatments Tested in This Trial?

Interventions

• Sensory-Adapted Dental Environment

Trial Overview The study tests a Sensory-Adapted Dental Environment (SADE) that includes dim lighting, noise-canceling headphones, and gentle dental tools aimed at reducing anxiety and improving behavior during dental visits for kids with sensory sensitivities.

How Is the Trial Designed?

Group I: SADE Group: Sensory-Adapted Dental Environment Experimental Treatment 1 Intervention

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 II: Control Group: Regular Dental Environment Active Control 1 Intervention

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

Sensory-Adapted Dental Environment is already approved in United States for the following indications:

Approved in United States as SADE for:

• Reducing anxiety in children with sensory processing disorders during dental visits
• Improving behavioral outcomes in children with sensory processing disorders during dental visits

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

A playful learning intervention significantly improved oral hygiene in children with hearing impairment, with the simplified oral hygiene index (OHI-S) scores increasing from 12% good status before the intervention to 64% after.

The study highlights the effectiveness of using educational strategies in Mexican Sign Language to promote oral health among children with sensory deficits, suggesting that such approaches can be beneficial in dental care for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Playful Educational Intervention for Improvement of Oral Health in Children with Hearing Impairment. Ávila-Curiel, BX., Solórzano-Mata, CJ., Avendaño-Martínez, JA., et al.[2022]

The study involved 19 children aged 6-11 years and assessed the effectiveness of a Snoezelen sensory adapted dental environment (SDE) in reducing anxiety during dental procedures.

Results showed significant improvements in both behavioral and physiological measures of relaxation in the SDE compared to a conventional dental setting, suggesting that the SDE is a practical and effective option for helping anxious children during dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural and physiological effect of dental environment sensory adaptation on children's dental anxiety. Shapiro, M., Melmed, RN., Sgan-Cohen, HD., et al.[2022]

A sensory adapted environment (SAE) significantly reduced anxious behaviors in both children with developmental disabilities and typical children during a stressful dental procedure, with anxious behaviors lasting an average of 5.26 minutes in the SAE compared to 13.56 minutes in the regular environment (P < .001).

Children with developmental disabilities showed a greater improvement in arousal levels when in the SAE, as indicated by lower electrodermal activity measurements before and during treatment, suggesting that they benefit more from sensory adaptations compared to typical children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of adapted environment on the anxiety of medically treated children with developmental disability. Shapiro, M., Sgan-Cohen, HD., Parush, S., et al.[2009]

In a pilot study involving 22 children with developmental disabilities, the sensory adapted dental environment (SADE) led to significantly higher cooperation scores during dental cleanings compared to the regular dental environment (RDE).

Despite no differences in physiological measures like heart rate and oxygen saturation, 46% of parents preferred the SADE for future visits, suggesting it may enhance the dental experience for children with developmental disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of sensory adapted dental environment on children with developmental disabilities. Kim, G., Carrico, C., Ivey, C., et al.[2019]

A study involving children aged 8-13 with mild intellectual disabilities showed that a sensory-adapted dental environment (SADE) significantly reduced anxiety levels during dental procedures compared to a regular dental environment.

SADE not only decreased anxiety but also improved cooperative behavior in these children, suggesting it could be an effective alternative for managing behavior in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing special care dentistry with sensory-adapted dental environment: A comparative study. Kittur, S., Basappa, N., Raju, OS., et al.[2022]

A sensory-adapted dental environment (SADE) significantly reduced anxiety and increased cooperation in children with developmental disabilities during dental hygiene procedures, compared to a regular dental environment (RDE).

In the SADE, anxious behaviors were reduced by over 60% in duration and magnitude, and cooperation levels were dramatically higher, suggesting that nonpharmacological approaches can effectively improve dental experiences for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sensory adaptation on anxiety of children with developmental disabilities: a new approach. Shapiro, M., Melmed, RN., Sgan-Cohen, HD., et al.[2011]

Implementing Snoezelen multisensory calming strategies in a community dental practice significantly improved patient behavior, cooperation, and satisfaction, particularly for individuals with disabilities.

The calming environment reduced the need for sedation or general anesthesia, suggesting that similar multisensory features in dental clinics could enhance access to care for patients with special needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Multisensory/Snoezelen Environment to Optimize the Dental Care Patient Experience. Sigal, A., Sigal, M.[2022]

Parents of children with autism spectrum disorders (ASD) reported significantly more challenges related to sensory experiences during oral care at home and at the dentist compared to parents of typically developing (TD) children, based on responses from 196 ASD and 202 TD families.

Implementing sensory strategies to modify the dental environment could improve the dental experience and overall quality of life for children with ASD and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral care and sensory concerns in autism. Stein, LI., Polido, JC., Cermak, SA.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4554774/

Sensory Adapted Dental Environments to Enhance Oral ... This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06912854

Sensory Adapted Dental Environments to Enhance Oral ... This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a ...

3. mdpi.com mdpi.com/2227-9067/9/3/393

Sensory-Adapted Dental Environment for the Treatment of ... Results suggest that a sensory-adapted environment positively affects the therapeutic dental treatment in patients with ASD.

4. chan.usc.edu chan.usc.edu/research/labs/sade

Sensory Adaptations in Dental Environments (SADE) The Sensory Adaptations in Dental Environments lab, led by Sharon Cermak, studies interventions that alter the sensory characteristics of the dental ...

5. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/counter/pdf/10.1186/s12903-023-03445-6.pdf

Effectiveness of sensory adaptive dental environments to ... Dental anxiety has been found to be linked towards poorer oral health care outcomes for the general popu- lation across multiple studies [25–27]. Dental anxiety ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2805513

Sensory Adaptations to Improve Physiological and ... These findings suggest that using a SADE during dental cleanings was a safe and efficacious way to improve dental experiences for autistic children.