Autism Spectrum DisorderNCT06355141
Oral Structural and Functional Problems in Children With Autism
An observational study of Autism Spectrum Disorder and Chewing Problem, run by Hacettepe University.
Trial summary
This study aims to examine oral structural and functional problems in children with autism. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Autism Spectrum Disorder, Chewing Problem, Drooling
- What is being tested?
- oral assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2024to 12 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Diagnosed with autism,
- Not having any additional diagnosis other than autism,
- Age between 5-15 yers
Who cannot join
- Not being able to receive the commands required to obtain working data.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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?
- Conditions
- Autism Spectrum Disorder, Chewing Problem, Drooling
- Being tested
- oral assessment
- Keywords
- autism, chewing, drooling
- Medical subject headings
- Autism Spectrum Disorder, Sialorrhea, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral assessmentOther
observational oral assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Form
Descriptive information will be recorded.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start11 Apr 2024 (estimated)
- Primary completion13 May 2024 (estimated)
- Study completion12 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Kübra Şahan, Hacettepe University
- Investigators
- Ayşe Kübra Söyler, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355141
- Sponsor's protocol ID
- E-15189967-050.04-494458
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Oral Structural and Functional Problems in Children With Autism Secondary IDs:
- ClinicalTrials.gov ID
- NCT06355141
- Acronym / sponsor ID
- E-15189967-050.04-494458
- Conditions
- Autism Spectrum Disorder, Chewing Problem, Drooling
- Keywords
- autism, chewing, drooling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 11 Apr 2024 (estimated)
- Primary completion
- 13 May 2024 (estimated)
- Study completion
- 12 Aug 2024 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine oral structural and functional problems in children with autism.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Diagnosed with autism,
- Not having any additional diagnosis other than autism,
- Age between 5-15 yers
Key exclusion criteria (1 listed)
- Not being able to receive the commands required to obtain working data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral assessmentobservational oral assessment | Other | – |
Primary outcome
Demographic Information Form
Time frame: 1 month
Descriptive information will be recorded.
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.
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.
3 secondary outcomes
Chewing evaluation
Time frame: 1 month
Drooling of saliva evaluation
Time frame: 1 month
Tongue thrust evaluation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Kübra Söyler principal investigator
Aydin Adnan Menderes University
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Chewing Problem, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Kübra Söyler, PhD (553 925 43 46, ayse.kubra.sahan@adu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.