ClinicalTrials.gg
Not yet recruitingNCT06355141Updated Apr 9, 2024

Oral Structural and Functional Problems in Children With Autism

An observational study in Autism Spectrum Disorder, Chewing Problem and Drooling, sponsored by Hacettepe University. Not yet recruiting. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-04-09.

Primary conditionAutistic DisorderRegistry: Autism Spectrum DisorderReclassifiedWhy we changed it
Registry
Autism Spectrum Disorder — the first condition term the registry derived for this study.
ClinicalTrials.gg
Autistic Disorder
Why
  1. The study's listed conditions name Autistic Disorder, a narrower term within Autism Spectrum Disorder.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Hacettepe University · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
5 Years to 15 Years
Sex
All
01

Study summary

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

Read the 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?

02

Conditions studied

  • Autism Spectrum Disorder
  • Chewing Problem
  • Drooling

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Keywords

  • autism
  • chewing
  • drooling
03

In context

Autistic Disorder Reclassified

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 90 is below the median of 101 across 189 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with autism,
  • Not having any additional diagnosis other than autism,
  • Age between 5-15 yers

Exclusion criteria

Exclusion Criteria:

  • Not being able to receive the commands required to obtain working data.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Otheroral assessment

    observational oral assessment

06

What researchers measure

Primary outcomes

  1. Demographic Information Form

    Descriptive information will be recorded.

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

  3. 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.

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

  3. 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.

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06355141
Responsible party
Ayşe Kübra Şahan (Principal investigator, Hacettepe University) — Principal investigator
First posted
Apr 9, 2024
Start date
Apr 11, 2024 (estimated)
Primary completion
May 13, 2024 (estimated)
Completion
Aug 12, 2024 (estimated)
Last update
Apr 9, 2024

Study contacts

Ayşe Kübra Söyler, PhD
Contact
ayse.kubra.sahan@adu.edu.tr
553 925 43 46
Ayşe Kübra Söyler
principal investigator · Aydin Adnan Menderes University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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