Oral Structural and Functional Problems in Children With Autism

April 3, 2024 updated by: Ayşe Kübra Şahan, Hacettepe University

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

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

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed 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?

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children with autism (CwA) are five times more likely to experience feeding-related problems than their typically developing peers. Oral functional problems (chewing disorder, drooling of saliva), food selectivity, inappropriate mealtime interaction, abnormal eating speed (holding food in the mouth for a long time or fast feeding) and failure to eat the usual family diet are feeding-related reported in CwA.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Information Form
Time Frame: 1 month
Descriptive information will be recorded.
1 month
Time to achieve Oromotor skills
Time Frame: 1 month
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
Oral structural assessment
Time Frame: 1 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chewing evaluation
Time Frame: 1 month
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
Drooling of saliva evaluation
Time Frame: 1 month
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
Tongue thrust evaluation
Time Frame: 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayşe Kübra Söyler, Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 11, 2024

Primary Completion (Estimated)

May 13, 2024

Study Completion (Estimated)

August 12, 2024

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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