Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder

NCT ID: NCT04576559

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-08-30

Brief Summary

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There is a need to find an approach that is appropriate for managing children with Autism Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children during the dental appointment.

Detailed Description

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Conditions

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Child Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Modified dental visual aids

Group Type EXPERIMENTAL

Modified dental visual aids

Intervention Type OTHER

Modified Dental visual aids in the form of pictures created by the main investigator

Regular dental visual aids

Group Type ACTIVE_COMPARATOR

Regular dental visual aids

Intervention Type OTHER

Regular dental visual aids

Interventions

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Modified dental visual aids

Modified Dental visual aids in the form of pictures created by the main investigator

Intervention Type OTHER

Regular dental visual aids

Regular dental visual aids

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient age between 6-10 years.
* Child patient has to represent the typical triad symptoms of ASD that include: social interaction deficits, communication impairment, language impairment and rigidity of interests.
* Child patient with ASD diagnosis confirmed in the patient's files according to "the DSM-V criteria" (American Psychiatric Association, 2013).
* Child patient with mild to moderate ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).

Exclusion Criteria

* Patient age younger than 6 years and older than 10 years.
* Child patient with other congenital anomalies, for example, "Cerebral Palsy" or "Down Syndrome".
* Child patient with previous dental experience.
* Child patient with severe ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Ala Aljubour

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Abdulaziz University

Jeddah, Select A State Or Province, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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KingAbdulazizUni

Identifier Type: -

Identifier Source: org_study_id

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