Trial results for a study on Sensory Adapted Dental Environments (SADE) to improve oral care for children with Autism were posted on ClinicalTrials.gov on 2025-08-19. The study enrolled 220 participants.
Background
Children with Autism Spectrum Disorders (ASD) often experience difficulties tolerating oral care in traditional dental clinic settings. These challenges can stem from sensory sensitivities, leading to increased anxiety, reduced cooperation, and problematic behaviors during dental visits. Adapting the dental environment to address these sensory needs has the potential to enhance comfort for children with ASD, leading to safer, more efficient, and potentially less costly dental treatment.
Trial design
This completed study, which did not specify a phase, enrolled 220 participants diagnosed with Autism. The trial aimed to examine the efficacy of a sensory adapted dental environment (SADE) for children who experience difficulty with oral care. The intervention involved modifying the sounds, sights, and tactile experiences within the dental office. Participants were evaluated in both a regular dental environment and a sensory adapted dental environment.
Key results
The study collected several key measurements to assess the impact of the sensory adapted dental environment:
- Electrodermal Activity (EDA) - Skin Conductance Level (SCL):
- In the Regular Dental Environment, the mean SCL was 8.96 microsiemens (µS) (Standard Deviation 5.29).
- In the Sensory Adapted Dental Environment, the mean SCL was 7.74 microsiemens (µS) (Standard Deviation 4.85).
- Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR):
- In the Regular Dental Environment, the mean NS-SCR was 4.25 number of NS-SCRs per minute (frequency) (Standard Deviation 3.03).
- In the Sensory Adapted Dental Environment, the mean NS-SCR was 3.90 number of NS-SCRs per minute (frequency) (Standard Deviation 2.72).
- Children's Dental Behavior Rating Scale (CDBRS):
- In the Regular Dental Environment, the mean CDBRS score was 46.41 (Standard Deviation 11.78).
- In the Sensory Adapted Dental Environment, the mean CDBRS score was 46.10 (Standard Deviation 10.77).
- Whimper, Cry, Scream Duration:
- In the Regular Dental Environment, the mean duration was 44.26 minutes (Standard Deviation 68.39).
- In the Sensory Adapted Dental Environment, the mean duration was 19.70 minutes (Standard Deviation 43.56).
- Whimper, Cry, Scream Frequency:
- In the Regular Dental Environment, the mean frequency was 9.83 events (Standard Deviation 9.96).
- In the Sensory Adapted Dental Environment, the mean frequency was 6.02 events (Standard Deviation 7.10).
- Mouth Movement Frequency:
- In the Regular Dental Environment, the mean frequency was 5.43 events (Standard Deviation 6.32).
- In the Sensory Adapted Dental Environment, the mean frequency was 3.20 events (Standard Deviation 4.15).
Key analyses indicated:
- A mixed-effects regression model yielded a p-value of 0.01.
- Another mixed-effects regression model yielded a p-value of 0.25.
- A Wilcoxon (Mann-Whitney) analysis yielded a p-value of 0.87.
- A Wilcoxon (Mann-Whitney) analysis yielded a p-value of 0.001.
- A Wilcoxon (Mann-Whitney) analysis yielded a p-value of 0.001.
- A Wilcoxon (Mann-Whitney) analysis yielded a p-value of 0.001.
What this means
The results suggest that a sensory adapted dental environment can significantly reduce distress behaviors in children with Autism during oral care. Notably, the mean duration of whimper, cry, and scream events was substantially lower in the Sensory Adapted Dental Environment (19.70 minutes) compared to the Regular Dental Environment (44.26 minutes). Similarly, the frequency of these distress behaviors decreased from a mean of 9.83 events to 6.02 events. Mouth movement frequency also saw a reduction from a mean of 5.43 events to 3.20 events in the adapted environment. These improvements are supported by highly significant p-values (0.001 for multiple Wilcoxon analyses). The reduction in Electrodermal Activity (SCL) from 8.96 µS to 7.74 µS, with a p-value of 0.01 from a mixed-effects regression model, further indicates decreased physiological arousal. However, the Children's Dental Behavior Rating Scale (CDBRS) showed minimal change between environments, with a mean of 46.41 in the regular setting and 46.10 in the adapted setting, and a non-significant p-value of 0.87.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02430051, titled "Sensory Adapted Dental Environments to Enhance Oral Care for Children", were posted on 2025-08-19 on clinicaltrials.gov.