- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06355141
Oral Structural and Functional Problems in Children With Autism
Investigation of Oral Structural and Functional Problems in Children With Autism Secondary IDs:
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ayşe Kübra Söyler, PhD
- Phone Number: 553 925 43 46
- Email: ayse.kubra.sahan@adu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Ayşe Kübra Söyler, Aydin Adnan Menderes University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-15189967-050.04-494458
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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