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Clinical Trials/NCT03366467
NCT03366467
Withdrawn
Not Applicable

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

Hadassah Medical Organization0 sitesMarch 22, 2022
ConditionsChild Behavior

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Behavior
Sponsor
Hadassah Medical Organization
Primary Endpoint
Physiologic arousal states
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief 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).

Detailed Description

* Dental treatment- will include restorations, crowns, pulp treatment, with local anesthesia. The use of oral/inhaled sedation will be decided according to the patient's behavior and cooperation assessment. * Dental settings- 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. The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation. * Instruments- 1) the children will be observed during the treatments. The observer will code all behaviors according to the Houpt Scale used for rating patient behavior during treatment. In addition, the examiner will count the number and duration (in minutes) of the anxious behavior (crying and movements). Because of the nature of the study (one environment with sensory adaptation and the other without), the observer cannot be blind to the treatment environment. 2) Physiologic arousal states, evaluated by the assessment of EDA (Mindlife Co, Jerusalem, Israel). Changes in the electrical conductance of the skin are a sensitive way of monitoring autonomic responses to external stimuli.

Registry
clinicaltrials.gov
Start Date
March 22, 2022
End Date
March 22, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Avia Fux

pediatric dentist

Hadassah Medical Organization

Eligibility Criteria

Inclusion Criteria

  • Needs at least 2 similar dental treatment appointments

Exclusion Criteria

  • Needs only one dental treatment

Outcomes

Primary Outcomes

Physiologic arousal states

Time Frame: Data will be reported through study completion, an average of 2 years

Evaluated by palmar electrodermal activity (EDA) during dental treatment

Secondary Outcomes

  • Anxious behavior-duration(Data will be reported through study completion, an average of 2 years)
  • Houpt Scale(Data will be reported through study completion, an average of 2 years)
  • Anxious behavior-number(Data will be reported through study completion, an average of 2 years)

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