Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06912854

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
312 (estimated)
Sponsor
University of Southern California · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERSensory Adapted Dental EnvironmentThe 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.
OTHERVideo-based ModelingParticipants 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.

Timeline

Start date
2025-05-09
Primary completion
2029-03-01
Completion
2029-03-01
First posted
2025-04-06
Last updated
2025-10-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06912854. Inclusion in this directory is not an endorsement.