An interventional study of SADE and RDE in Child Behavior, sponsored by Hadassah Medical Organization. Withdrawn. Open to participants aged 3 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Other
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).
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
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Exclusion Criteria:
SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2)
Other: SADE · Other: RDE
RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2)
Other: SADE · Other: RDE
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.
Physiologic arousal states
Evaluated by palmar electrodermal activity (EDA) during dental treatment
Time frame: Data will be reported through study completion, an average of 2 years
Houpt Scale
Rating patient behavior during treatment according to Houpt scale. The Houpt scale is a tool used to assess a child's behavior during dental sedation according to specific categories and scores including: sleep (1-awake, 2-drowsy, disoriented), movement (1-violent, 2-continuous, 3-controllable, 4-no movement), cry (1-hysterical, 2-continuous, 3-intermittent, 4-no cry), and overall behavior (1-treatment aborted, 2-poor, 3-regular, 4-good, 5-very good, 6-excellent).
Time frame: Data will be reported through study completion, an average of 2 years
Anxious behavior-number
Examiner will count the number of the anxious behavior episodes (crying and movements) during dental treatment.
Time frame: Data will be reported through study completion, an average of 2 years
Anxious behavior-duration
Examiner will count the duration, in minute, of the anxious behavior (crying and movements) during dental treatment..
Time frame: Data will be reported through study completion, an average of 2 years
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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