ClinicalTrials.gg
Not yet recruitingNCT06280651OHIDPAP-CSUpdated Mar 15, 2024

Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis

An observational study in Dental Caries in Children, Autistic Disorder and Dietary Habits, sponsored by King Khalid University. Not yet recruiting. Open to participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by King Khalid University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

The study investigates oral health implications of dietary preferences in autistic children, revealing diverse oral statuses and emphasizing tailored interventions. Key findings include significant associations between hygiene practices, periodontal disease, and dietary choices. The research highlights the need for personalized dental care, influenced by factors like age, gender, family income, parental education, and ASD severity. The study contributes to understanding oral health challenges in autistic children, suggesting dietary factors play a crucial role in oral health outcomes, calling for targeted strategies to improve their dental well-being.

02

Conditions studied

  • Dental Caries in Children
  • Autistic Disorder
  • Dietary Habits

Keywords

  • Oral Health
  • Dietary Preferences
  • Autistic Paediatric Population
  • Oral Hygiene
03

In context

Autistic Disorder

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

This study's planned enrollment of 50 is below the median of 101 across 189 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

King Khalid University is the lead sponsor of 18 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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

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

Exclusion criteria

Exclusion Criteria:

  • Challenges that may impact study outcomes include coexisting medical conditions.
  • Severe behavioral issues that may impede participation.
  • Difficulties in obtaining , posing obstacles to comprehensive research endeavors.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Otherdietary preferences and their implications for oral health in children with Autism Spectrum Disorder

    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.

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — The IPD Sharing Plan aims to advance research in oral health and dietary preferences in autistic children, ensuring data privacy. It includes sharing anonymized participant data (demographics, dietary habits, oral health status) and study methodologies. Data access requires a review for ethical soundness, a commitment to confidentiality, and is limited to affiliated researchers. This fosters collaboration while protecting participant information.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2024; primary completion for Apr 2024, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2024
First posted
Feb 28, 2024
StartEst.
Mar 25, 2024
Primary completionEst.
Apr 30, 2024
CompletionEst.
May 15, 2024
Last update
Mar 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06280651
Lead sponsor
King Khalid University
Responsible party
Sunil Kumar Vaddamanu (ASSITANT PROFESSOR, King Khalid University) — Principal investigator
First posted
Feb 28, 2024
Start date
Mar 25, 2024 (estimated)
Primary completion
Apr 30, 2024 (estimated)
Completion
May 15, 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Sunil Kumar, MDS
Contact
snu@kku.edu.sa
+966595220377

Oversight

Data monitoring committee
No
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 Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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