Sensory Adapted Dental Environment for Dental Phobia

(SADE-DFA Trial)

Overseen By Riley McGuire, OTD, OTR/L, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Anti-cholinergic drugs

Disqualifiers: Intellectual disability, Orthodontia, others

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

Compensation: Varies

Number of Visits: 2

Duration: Single session

312 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to make dental cleanings less intimidating for anxious children. It compares a regular dental setting with a Sensory Adapted Dental Environment (SADE) and a video of a calm dental visit to determine which best reduces fear and discomfort. The study includes children aged 6 to 12 who have had at least one dental cleaning and can speak English or Spanish. As an unphased trial, it provides a unique opportunity for children to experience innovative approaches that could make dental visits more comfortable.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if your child uses anti-cholinergic drugs daily, they cannot participate in the study.

What prior data suggests that the Sensory Adapted Dental Environment and Video-based Modeling are safe for children?

A previous study found that using a Sensory Adapted Dental Environment (SADE) during dental cleanings is safe and helpful for children, especially those with autism. The study showed that SADE improved the dental visit without causing harm or discomfort. This environment includes calming lights, sounds, and touch, such as soft music and a weighted blanket for comfort.

Research on Video-based Modeling (VBM) has shown it to be effective in reducing anxiety during dental visits. Participants watch a short video of a child calmly undergoing a dental cleaning, which helps reassure and prepare them for their own experience. No negative side effects have been reported from watching these videos.

Both approaches are well-tolerated and have improved the dental experience for children. Strong evidence supports their safety in reducing dental anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sensory Adapted Dental Environment (SADE) and Video-based Modeling (VBM) treatments for dental phobia because they offer innovative ways to reduce anxiety during dental visits. Unlike traditional methods that rely on basic behavior guidance, SADE transforms the dental setting itself by adjusting lighting, playing calming music, and using weighted blankets to create a more relaxing atmosphere. VBM takes a different approach by showing children a video of a peer having a stress-free dental cleaning, helping to set positive expectations. Together, these approaches have the potential to make dental visits less intimidating for children, encouraging better oral health habits.

What evidence suggests that this trial's treatments could be effective for reducing dental phobia in children?

Research has shown that Sensory Adapted Dental Environments (SADE), a treatment option in this trial, can make dental visits less intimidating and uncomfortable for children. These environments adjust lighting, sounds, and touch to create a soothing atmosphere. Studies have found this approach particularly helpful for children with autism. Another treatment option in this trial is Video-based Modeling (VBM), which involves watching a video of a calm dental visit to reduce anxiety by showing children what to expect. When combined, as in one of the trial arms, SADE and VBM can effectively make dental visits more comfortable and less stressful. ^{1 2 4 6 7}

Who Is on the Research Team?

Leah Stein Duker, PhD, OTR/L

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for children aged 6-12 who have had at least one dental cleaning and can speak English or Spanish. It's not for kids who've had a recent cleaning, plan to move soon, have certain disabilities like autism or cerebral palsy, take daily anti-cholinergic drugs, or will get braces within 6 months.

Inclusion Criteria

I am between 6 and 12 years old.

My child and I can speak English or Spanish.

If recruited from the emergency department, Emergency Severity Index (ESI) must be level V or IV (to ensure that greater severity PED patients not be recruited)

Exclusion Criteria

I had a dental cleaning in the last 4 months.

Plan to move out of the area within 6 months

Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dental cleaning in different environments: Regular Dental Environment (RDE), Video-based Modeling (VBM), Sensory Adapted Dental Environment (SADE), or a combination of VBM and SADE.

Single session

1 visit (in-person)

Follow-up

Participants are monitored for anxiety, distress behavior, pain, and sensory discomfort immediately after the dental cleaning.

Immediate post-procedure

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sensory Adapted Dental Environment
• Video-based Modeling

Trial Overview The study compares the effects of a Sensory Adapted Dental Environment (SADE) alone and with video-based modeling (VBM), against regular dental environments and VBM alone. The goal is to see which setting best reduces anxiety and discomfort during dental cleanings in kids with or without dental fears.

How Is the Trial Designed?

Group I: Video-based Modeling + Sensory Adapted Dental Environment (VBM-SADE) Experimental Treatment 2 Interventions

Participants randomized to VBM-SADE will view a modeling video prior to their dental cleaning (see Video-based Modeling description) and experience their dental cleaning in a sensory adapted dental environment (see Sensory Adapted Dental Environment description); the pre-cleaning modeling video will portray the same procedural content as in the VBM-only condition, but with the SADE modifications made to the room in which the child actor receives his/her cleaning.

Group II: Video-based Modeling (VBM) Experimental Treatment 1 Intervention

Participants randomized to VBM will view a 5-minute video on an iPad that depicts a dental cleaning (oral examination, prophylaxis, and fluoride varnish application) being performed on a sex and age-matched (6-9 yrs v.s 10-12 yrs) cooperative child. This video will feature the model beginning in the waiting room, undertaking a successful cleaning in the absence of any signs of anxiety, choosing a small toy from the dental clinic treasure box, and receiving parental and dentist praise for good behavior.

Group III: Sensory Adapted Dental Environment (SADE) Experimental Treatment 1 Intervention

Participants randomized to the SADE will receive their dental cleaning in a environment in which modifications have been made to visual, auditory, and deep pressure (tactile) stimuli to minimize sensory-related discomforts and maximize relaxation. Visual adaptations include: all direct overhead fluorescent lighting and dental overhead lamp will be turned off; black-out curtains will cover the windows; and application of adapted lighting, which will include slow moving visual color effects (Snoezelen) and the dentist wearing a surgical dental headlamp to direct light into the child's mouth, not eyes. Auditory stimuli will include calming rhythmic music projected via portable speakers. Tactile deep pressure stimuli will be provided via a commercially available weighted blanket placed on the child to provide deep "hugging" pressure, which produces a calming effect.

Group IV: Regular Dental Environment (RDE) Active Control 1 Intervention

Participants randomized to a RDE will have their dental cleaning administered in a traditional manner (oral examination, prophylaxis, fluoride application) using tell-show-do and basic behavior guidance techniques including positive reinforcement.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

Dental anxiety and phobia are common issues that can lead to avoidance of dental care, making it crucial for dentists to identify and address these concerns early through subjective evaluations and objective assessments of physiological responses.

Management of dental anxiety can involve a combination of psychotherapeutic interventions, like cognitive behavior therapy, and pharmacological options such as sedation or general anesthesia, tailored to the patient's anxiety level and willingness to engage in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to manage patients with dental anxiety and dental phobia: literature review. Appukuttan, DP.[2022]

A systematic review of 12 randomized controlled trials involving 818 pediatric patients found that virtual reality (VR) distraction interventions significantly reduced dental anxiety, pain, and heart rate during dental treatments, indicating their effectiveness as a management tool.

Despite the positive results, the evidence for VR's effectiveness in reducing dental anxiety may be weakened by publication bias, highlighting the need for more high-quality studies to confirm these findings and optimize VR delivery in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. Yan, X., Yan, Y., Cao, M., et al.[2023]

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]

This study investigates the efficacy of Virtual Reality Exposure Therapy (VRET) for dental phobia, comparing it to an informational pamphlet control group, with 30 participants aged 18-50 and follow-ups at 1 week, 3 months, and 6 months.

The study aims to measure reductions in dental anxiety and physiological arousal (heart rate) during VRET, potentially establishing VRET as a non-invasive alternative treatment for dental anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial. Raghav, K., Van Wijk, AJ., Abdullah, F., et al.[2022]

A study involving 306 survey participants and 18 interviewees found that vivid sensory images related to dental experiences are common among individuals, but those with higher dental anxiety reported more distressing and fear-provoking imagery linked to negative past experiences.

Participants with lower anxiety levels tended to have more positive and reassuring imagery, suggesting that focusing on positive outcomes could help reduce dental anxiety and improve attendance at dental appointments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental imagery in dentistry: Phenomenology and role in dental anxiety. Schneider, A., Andrade, J., Tanja-Dijkstra, K., et al.[2019]

A new measurement tool for dental anxiety was tested on 452 participants, revealing two distinct types of phobias: 'generalized' phobias and 'dental specific' phobias, indicating that dental fears are relatively independent from other types of anxiety.

The study developed four reliable scales to assess different anxiety symptoms, which can help differentiate between patients experiencing panic attacks and those who do not, suggesting a more nuanced understanding of anxiety in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental anxiety--the development of a measurement model. Weiner, AA., Sheehan, DV., Jones, KJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10585952/

Effectiveness of sensory adaptive dental environments ... This study aimed to systematically review the evidence on the effectiveness of sensory adaptive dental environments (SADE) for children and young adults

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 video ...

3. chan.usc.edu chan.usc.edu/research/projects/sensory-adapted-dental-environments-to-enhance-oral-care-for-children-with-and-without-dental-fear-and-anxiety

Sensory Adapted Dental Environments to Enhance Oral Care ... Long-term project outcomes will have excellent potential to benefit countless children in the US who manifest disruptive anxiety reactions in the dental clinic.

4. 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.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/scd.13003

Effect of Sensory Adapted Dental Environment (SADE) on ... Many studies reported that there is greater amount of physiological and behavioral stress faced by children with ASD during routine oral care.

6. 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 ...

7. cureus.com cureus.com/articles/250661-efficiency-of-a-sensory-adapted-dental-environment-versus-regular-dental-environment-in-neurotypically-healthy-children-a-parallel-arm-interventional-study

Efficiency of a Sensory-Adapted Dental Environment ... Overall, our study suggests that dental offices can significantly enhance patient experiences by providing a sensory-friendly setting that helps ...