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

Overview

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).

Full Title of Study: “Effect of Sensory Adapted Dental Environment on Children’s Behavior During Dental Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2020

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.

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.

Arms, Groups and Cohorts

  • Experimental: SADE first
    • SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2)
  • Experimental: RDE first
    • RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Houpt Scale
    • Time Frame: Data will be reported through study completion, an average of 2 years
    • 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).
  • Anxious behavior-number
    • Time Frame: Data will be reported through study completion, an average of 2 years
    • Examiner will count the number of the anxious behavior episodes (crying and movements) during dental treatment.
  • Anxious behavior-duration
    • Time Frame: Data will be reported through study completion, an average of 2 years
    • Examiner will count the duration, in minute, of the anxious behavior (crying and movements) during dental treatment..

Participating in This Clinical Trial

Inclusion Criteria

  • ASA1
  • Needs at least 2 similar dental treatment appointments

Exclusion Criteria

  • Needs only one dental treatment

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Principal Investigator: Avia Fux, pediatric dentist – Hadassah Medical Organization

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