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Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment

NCT03366467 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-04

No results posted yet for this study

Summary

The objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment.

the study is a random cross-over design. The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental environment (RDE) on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).

Conditions

  • Child Behavior

Interventions

OTHER

SADE

The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers.

OTHER

RDE

The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2022-03-22
Completion
2022-03-22

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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 NCT03366467 on ClinicalTrials.gov