Skip to main content
OpenTrials
Completed

NCT Number: NCT04576559

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Child Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, Select A State Or Province, 21589, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Modified dental visual aids

Other

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

Regular dental visual aids

Other

Regular dental visual aids

Primary outcomes

  1. Plaque Index Scoring

    Time frame: four weeks

    plaque index scoring (Silness and Löe, 1964)

  2. Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)

    Time frame: four weeks

    This scale contains twenty-four "self-report" questions that inquire about anxiety, it contains 4 sub-scales including:

    • Separation Anxiety (SA).
    • Uncertainty (U).
    • Performance Anxiety (PA).
    • Anxious Arousal (AA). It is a four-point "Likert-scale"; items in the questionnaire are rated from zero ("never") to three ("always"). Another version of the same scale with twenty-four questions directed to the parents will also be used and it contains a report of their child's symptoms of anxiety, within the same four subscales (Rodgers et al., 2016).

  3. The Observational Scale of Behavioral Distress (OSBD)

    Time frame: four weeks

    This scale is used to measure the behavioral distress that a child experiences when undergoing a painful procedure. This scale is composed of eight operationally defined behaviors that are indicative of anxiety and/or pain behavior in children. The OSBD is a valid and reliable scale that measures distress in children receiving painful procedures in the medical and dental practice, for example, venipuncture and needle injections (Elliot et al., 1987).

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2020
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.