N/A
Completed N=163
Sensory Adapted Dental Environments to Enhance Oral Care for Children
Source: ClinicalTrials.gov NCT02430051 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Electrodermal Activity (EDA) - Skin Conductance Level (SCL) — 8.96; 7.74 microsiemens (µS) — p=0.01
Summary
The goal of this project is to examine the efficacy of a sensory adapted dental environment (SADE) for children who have difficulty tolerating oral care in the dental clinic. The investigators hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights,and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders (ASD). This has the potential to contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Electrodermal Activity (EDA) - Skin Conductance Level (SCL) |
8.96; 7.74 | 0.01 sig |
| PRIMARY Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR) |
4.25; 3.90 | 0.25 |
| SECONDARY Children's Dental Behavior Rating Scale (CDBRS) |
46.41; 46.10 | 0.87 |
| SECONDARY Whimper, Cry, Scream Duration |
44.26; 19.70 | <0.001 sig |
| SECONDARY Whimper, Cry, Scream Frequency |
9.83; 6.02 | <0.001 sig |
| SECONDARY Mouth Movement Frequency |
5.43; 3.20 | <0.001 sig |
| SECONDARY Head Movement Frequency |
16.36; 11.68 | <0.001 sig |
| SECONDARY Faces Pain Scale - Revised |
2.37; 2.14 | 0.92 |
| SECONDARY Dental Sensory Sensitivity Scale |
3.68; 3.06 | 0.16 |
| SECONDARY Anxiety and Cooperation Scale |
2.03; 1.88 | 0.76 |
| SECONDARY Frankl Scale |
2.61; 2.68 | 0.80 |
| SECONDARY Duration |
10.51; 10.20 | <0.0001 sig |
| SECONDARY Number of Hands Used to Restrain Child |
2.14; 1.83 | 0.61 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of autism using ADOS;
- Parents speak English or Spanish;
- Have experienced at least one prior dental cleaning;
- In need of an oral cleaning (no previous cleaning within past four months).
Exclusion Criteria
- Cleft palate or other oral condition which makes dental care more difficult than usual practice;
- Prescription of anti-cholinergic drugs (which may alter EDA);
- Presence of orthodontia (braces);
- Significant motor impairment, such as cerebral palsy;
- Any known genetic, endocrine, or metabolic dysfunctions;
- Participation in the R34 SADE pilot study;
- Any medical condition such as significant cardiac problems that would place the individual at increased risk in the study.
Data sourced from ClinicalTrials.gov (NCT02430051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.