Dental Caries in ChildrenOHIDPAP-CSNCT06280651
Dietary Impacts on Oral Health in Autistic Children: A Cross-Sectional Analysis
An observational study of Dental Caries in Children and Autistic Disorder, run by King Khalid University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Autistic Disorder, Dietary Habits
- What is being tested?
- dietary preferences and their implications for oral health in children with Autism Spectrum Disorder
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2024to 15 May 2024
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oral Health Implications of Dietary Preferences in Autistic Paediatric Population: A Cross-Sectional Study
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.
- Conditions
- Dental Caries in Children, Autistic Disorder, Dietary Habits
- Being tested
- dietary preferences and their implications for oral health in children with Autism Spectrum Disorder
- Keywords
- Oral Health, Dietary Preferences, Autistic Paediatric Population, Oral Hygiene
- Medical subject headings
- Autistic Disorder, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary preferences and their implications for oral health in children with Autism Spectrum DisorderOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start25 Mar 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Kumar Vaddamanu, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280651
- Sponsor's protocol ID
- RGP 2/348/44
- Other IDs
- RGP 2/348/44
- Acronym
- OHIDPAP-CS
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Implications of Dietary Preferences in Autistic Paediatric Population: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06280651
- Acronym / sponsor ID
- OHIDPAP-CS / RGP 2/348/44
- Conditions
- Dental Caries in Children, Autistic Disorder, Dietary Habits
- Keywords
- Oral Health, Dietary Preferences, Autistic Paediatric Population, Oral Hygiene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 28 Feb 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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| dietary preferences and their implications for oral health in children with Autism Spectrum DisorderThis 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. | Other | – |
Primary outcome
Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status
Time frame: 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children and Autistic Disorder, run by King Khalid 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 2 inclusion and 3 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 15 Mar 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 Sunil Kumar, MDS (+966595220377, snu@kku.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the association between oral hygiene and periodontal disease severity to identify potential implications of dietary preferences for oral health status (time frame: 3 months). 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 15 Mar 2024.