Oral Structural and Functional Problems in Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Investigation of Oral Structural and Functional Problems in Children With Autism Secondary IDs:

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355141
• Other study ID #: E-15189967-050.04-494458
• Status: Not yet recruiting
• Start date: April 11, 2024
• Est. completion date: August 12, 2024

Study information

• Verified date: April 2024
• Source: Hacettepe University
• Contact: Ayse Kübra Söyler, PhD
• Phone: 553 925 43 46
• Email: ayse.kubra.sahan[@]adu.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to examine oral structural and functional problems in children with autism.

Description:

In this descriptive study, children with autism will be screened for oral structural and functional problems. In this context, observational evaluation will be made. The presence of tongue thrust reflex, chewing performance and salivation control in children will be examined.Within the scope of the research, demographic data, parameters related to the oral motor development stage (time to transition to solid food and solid food, time to first teething) will be recorded according to parental report. Oral structural evaluation, including open mouth, high palate, oral hygiene and malocclusion, will be made observationally and recorded as present/absent. Within the scope of oral functional evaluation, tongue thrust reflex, chewing function and salivation control (dooling) will be evaluated.

The questions the investigators will test for this purpors; Q1:What oral structural and functional problems are seen in children with autism? Q2:What is the frequency of oral structural and functional problems seen in children with autism?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 12, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Diagnosed with autism,

• Not having any additional diagnosis other than autism,

• Age between 5-15 yers

Exclusion Criteria:

• Not being able to receive the commands required to obtain working data.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Chewing Problem
• Drooling
• Sialorrhea

Intervention

Other:
• oral assessment
observational oral assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic Information Form	Descriptive information will be recorded.	1 month
Primary	Time to achieve Oromotor skills	Parameters related to oromotor skills (transition time to additional food and solid food, initial teething time) were recorded based on a parental report.	1 month
Primary	Oral structural assessment	Oral structural evaluation, including open mouth, high-arched palate, oral hygiene and malocclusion, will be made observationally and recorded as present/absent. Evaluation of malocclusion will be made observationally while at rest. It will be recorded as normal, over jet, open bite, deep bite and cross bite present/absent.	1 month
Secondary	Chewing evaluation	Chewing function will be evaluated with the "Mastication Function Observation and Evaluation Tool (MOE, The Mastication Observation and Evaluation)". This tool includes an objective assessment of the chewing process in children. The child is monitored while eating a standard biscuit, and the observer scores the child's chewing skills based on 8 parameters. This assessment tool evaluates tongue movements, jaw movements, chewing time, food/saliva overflow, swallowing and coordination during chewing.	1 month
Secondary	Drooling of saliva evaluation	Drooling frequency and sverity scale (DFSS) will be used. Drooling severity is scored between 1 and 5. It is scored as 1 meaning no saliva and dry, and 5 meaning continuous flow to the body and objects. Frequency is scored between 1 and 4. 1 means no drooling, 4 means constantly drooling.	1 month
Secondary	Tongue thrust evaluation	The presence and severity of the tongue thrust will be evaluated with the Tongue ThrustRating Scale (TTRS). It evaluates the tongue thrust between 0 and 3 points. While 0 indicates that there is no tongue reflex, 3 indicates that the tongue is positioned outside the mouth, that is, a severe tongue thrust.	1 month