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

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).

Study Overview

• Status: Withdrawn
• Conditions: Child Behavior
• Intervention / Treatment: Other: SADE; Other: RDE

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA1
• Needs at least 2 similar dental treatment appointments

Exclusion Criteria:

• Needs only one dental treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SADE first; SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2)	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.
Experimental: RDE first; RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic arousal states	Evaluated by palmar electrodermal activity (EDA) during dental treatment	Data will be reported through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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..	Data will be reported through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: dental treatment; sensory adapted environment
• Other Study ID Numbers: 0469-17-HMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No