NCT06355141

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

April 11, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

March 9, 2024

Last Update Submit

April 3, 2024

Conditions

Keywords

autismchewingdrooling

Outcome Measures

Primary Outcomes (3)

  • Demographic Information Form

    Descriptive information will be recorded.

    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.

    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.

    1 month

Secondary Outcomes (3)

  • Chewing evaluation

    1 month

  • Drooling of saliva evaluation

    1 month

  • Tongue thrust evaluation

    1 month

Interventions

observational oral assessment

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum DisorderSialorrheaAutistic Disorder

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Ayşe Kübra Söyler

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Kübra Söyler, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 9, 2024

First Posted

April 9, 2024

Study Start

April 11, 2024

Primary Completion

May 13, 2024

Study Completion

August 12, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04