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

NCT03366467 | Withdrawn

• 1 other identifier: 0469-17-HMO
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Child Behavior

Keywords

dental treatment; sensory adapted environment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Anxious behavior-duration

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

Study Arms (2)

SADE first

EXPERIMENTAL

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

EXPERIMENTAL

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

Other: SADE; Other: RDE

Interventions

SADE OTHER

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.

RDE first; SADE first

RDE OTHER

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

RDE first; SADE first

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA1
• Needs at least 2 similar dental treatment appointments

You may not qualify if:

• Needs only one dental treatment

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric dentist

Model Details: The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive 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 Record Dates

• First Submitted: November 27, 2017
• First Posted: December 8, 2017
• Study Start: March 22, 2022
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03