Sensory-adapted dental care with optional video modeling for children with dental fear

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares a Sensory Adapted Dental Environment (SADE) alone and combined with video-based modeling (VBM-SADE) to a regular dental environment (RDE) and VBM alone during routine dental cleanings. Eligible children aged 6–12 who speak English or Spanish and have had at least one prior cleaning are randomized to one of the intervention arms before a cleaning appointment. Outcomes include observed distress behaviors, self-reported pain and sensory discomfort, and physiological measures of arousal during the procedure. The study is run at Children's Hospital Los Angeles in collaboration with the University of Southern California and the NIDCR.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged 6 through 12 years, of any race/ethnicity;
* English- or Spanish-speaking child and parent;
* Have experienced at least one prior dental cleaning;
* 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:

* Dental cleaning within the previous 4 months (i.e., not in need of cleaning);
* Plan to move out of the area within 6 months;
* Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties);
* Disability that would interfere with oral care (e.g. cleft lip/palate, cerebral palsy, genetic/endocrine/metabolic dysfunction) or medical condition that would place the child at increased risk during the study (e.g., uncontrollable seizures);
* Daily use of anti-cholinergic drugs (i.e., interferes with EDA recordings);
* Presence of orthodontia (braces) or with a plan to get braces in the upcoming 6 months

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Leah Stein Duker, PhD, OTR/L — University of Southern California
• Study coordinator: Leah Stein Duker, PhD, OTR/L
• Email: lstein@chan.usc.edu
• Phone: 323-442-0371

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.