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Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety

NCT06912854 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2025-10-02

No results posted yet for this study

Summary

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.

Conditions

  • Dental Fear and Anxiety

Interventions

OTHER

Sensory Adapted Dental Environment

The SADE condition consists of physical adaptations (visual, auditory, tactile modifications) to the dental environment meant to create a less anxiety-provoking sensory experience. Direct overhead fluorescent lighting and the regular dental overhead lamp will be turned off and darkening curtains will cover the windows. Adapted lighting will include slow moving visual color effects (Snoezelen) shining on the ceiling in the child's visual field. The dentist will wear a surgical dental headlamp directed into the patient's mouth, reducing bright lights shining in the child's eyes. Auditory stimuli will be calming rhythmic music (Dan Gibson's Exploring Nature) projected via portable speakers. The tactile deep pressure stimulus will be a commercially available weighted blanket (10-15% of the child's weight) placed on the child to provide deep "hugging" pressure, which produces a calming effect.

OTHER

Video-based Modeling

Participants will watch an approximately 5-minute video depicting a dental cleaning being performed on a sex and age-matched cooperative child, designed to expose the participant to the activities of the dental cleaning and thereby create a less anxiety-provoking dental experience.

Sponsors & Collaborators

  • Children's Hospital Los Angeles

    collaborator OTHER

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Leah Stein Duker, PhD, OTR/L · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912854 on ClinicalTrials.gov