NCT06280651

Brief Summary

The study aims to explore how dietary habits affect oral health in children with autism. By examining a cross-section of the autistic paediatric population, the research seeks to identify patterns or specific dietary preferences that may contribute to or mitigate oral health issues. This observational study does not intervene in participants' diets but observes existing habits and their oral health outcomes, aiming to provide insights that could guide better dietary recommendations and oral health practices for 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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 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

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

February 20, 2024

Last Update Submit

March 14, 2024

Conditions

Keywords

Oral HealthDietary PreferencesAutistic Paediatric PopulationOral Hygiene

Outcome Measures

Primary Outcomes (1)

  • Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status

    This objective aims to explore how dietary habits among autistic pediatric populations influence oral health outcomes, particularly focusing on the correlation between oral hygiene practices and the severity of periodontal diseases. The study seeks to provide insights that could inform the development of targeted interventions and preventive strategies to address oral health issues in children with autism, emphasizing the impact of dietary choices on oral health.

    3 months

Interventions

This study design typically does not involve interventions. Instead, it observes and analyzes existing conditions or behaviors-in this case, dietary preferences and their implications for oral health in children with Autism Spectrum Disorder (ASD)-without the researchers applying any specific treatment or experimental condition to the participants. The aim is to identify correlations or patterns at a specific point in time, rather than to assess the effects of an intervention.

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study examines the impact of dietary habits on oral health among children with Autism Spectrum Disorder (ASD). It assesses how specific dietary choices correlate with oral health outcomes, including dental caries and periodontal disease. Key findings highlight the significance of diet in oral health management for autistic children, underscoring the need for specialized dietary advice and oral care strategies. The research aims to inform caregivers and healthcare professionals about the importance of monitoring and adjusting dietary habits to improve oral health in the ASD pediatric population.

You may qualify if:

  • Children between the ages of 2 and 12 diagnosed with autism spectrum disorder are eligible to participate in the study.
  • Informed consent from parents or legal guardians is a prerequisite.

You may not qualify if:

  • Challenges that may impact study outcomes include coexisting medical conditions.
  • Severe behavioral issues that may impede participation.
  • Difficulties in obtaining informed consent, posing obstacles to comprehensive research endeavors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autistic DisorderFeeding Behavior

Interventions

Oral Health

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Central Study Contacts

Sunil Kumar, MDS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSITANT PROFESSOR

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

March 25, 2024

Primary Completion

April 30, 2024

Study Completion

May 15, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03