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

Trial Summary

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 data supports the effectiveness of the treatment Sensory Adapted Dental Environment, Video-based Modeling for dental phobia?

The research suggests that vivid sensory images can influence dental anxiety, with less distressing images potentially reducing anxiety and encouraging dental visits. This implies that treatments focusing on altering sensory experiences, like Sensory Adapted Dental Environment, may help manage dental phobia by creating more positive and reassuring sensory experiences. ^{1 2 3 4 5}

Is the Sensory Adapted Dental Environment safe for humans?

Research on the Sensory Adapted Dental Environment (SDE) for children shows it is safe and can help reduce anxiety and induce relaxation during dental visits. This suggests it is a safe option for managing dental anxiety. ^{3 6 7 8 9}

How does the Sensory Adapted Dental Environment treatment differ from other treatments for dental phobia?

The Sensory Adapted Dental Environment (SDE) treatment is unique because it modifies the dental setting to reduce anxiety by using dimmed lighting, vibroacoustic stimuli (sound and vibration), and deep pressure, creating a calming atmosphere. This approach contrasts with traditional methods that focus on direct exposure or informational interventions, offering a more sensory-focused and relaxing experience for patients with dental phobia. ^{6 9 10 11 12}

What is the purpose of this trial?

This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.

Research Team

Leah Stein Duker, PhD, OTR/L

Principal Investigator

University of Southern California

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mental imagery in dentistry: Phenomenology and role in dental anxiety. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Fear of the dentist. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of the Index of Dental Anxiety and Fear (IDAF-4C+). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality distraction interventions to reduce dental anxiety in paediatric patients: A systematic review and meta-analysis. [2023]

5. Denmark pubmed.ncbi.nlm.nih.gov

Acceptability of behaviour therapy for dental phobia. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Symptom provocation in dental anxiety using cross-phobic video stimulation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Dental anxiety--the development of a measurement model. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Behavioural and physiological effect of dental environment sensory adaptation on children's dental anxiety. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Characteristics of early unpleasant dental experiences. [2019]

11. Singapore pubmed.ncbi.nlm.nih.gov

Children's Responses to Sensory Stimuli and their Behavior in the Dental Office. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial. [2022]