Clinical trial NCT05197634: The Impact of Covid-19 Pandemic On The Children With Autism Spectrum Disorder
Official title: The Impact of Covid-19 Pandemic, On The Eating Habits, Lifestyle Changes and Traumatic Injuries In The Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism With High Cognitive Abilities
COVID-19 Pandemic
Keywords: ASD (autism spectrum disorder)
Covid-19
Dental trauma
Eating habits
Lifestyle changes
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul Kent University
First posted: 2022-01-19
Enrollment: 330
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 200 patients per month in the 3-14 age group who are being followed up with a diagnosis of autism from the Department of Child Psychiatry of Istanbul University, and 165 children will be selected by simple random sampling method from among the patients who applied to the clinic during the study period. On the other hand, healthy controls who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics between September 6, 2021 and March 31, 2022 and met the inclusion criteria will be included in the order of application to the outpatient clinic.

Brief summary: The Covid-19 outbreak has caused families and individuals to change their life routines and eating habits, and has affected their psychology, especially for children with autism, due to the change in their routines. These psychological changes may trigger the self-harming behavior that is very common in children with autism.

Dental trauma, a common problem in children and adolescents, can also be seen in individuals who need special care such as autism.

The aim of this study is to evaluate the susceptibility of children with autism to orofacial trauma during the pandemic period and compare them with the pre-pandemic period and the healthy group, as well as to question the lifestyle, nutritional habits, mood changes and oral health behaviors that may be related to the risk of trauma.

Detailed description: The study is being carried out in Istanbul University Department of Pediatric Dentistry, period between September 2021 - March 2022 following the ethics committee approval 2021/49. Patient parents are informed about the study following the initial dental examination of the patient and the written informed consents are obtained from parents of all participants included in the study.

The orofacial trauma history, dietary habits and lifestyle changes of children aged 3-14 years diagnosed with autism in Istanbul University Department of Child Psychiatry and healthy children applying to Istanbul University Faculty of Dentistry Department of Pediatric Dentistry will be evaluated through a questionnaire to be applied to their families.

Questionnaire;

* 13 questions to question the sociodemographic profile,
* 10 questions to question the child's systemic disease history, oral hygiene habits and oral health status,
* 12 questions to question eating habits,
* 6 questions to question the child's lifestyle and psychological changes due to the Covid-19 pandemic,
* 20 questions to question the trauma story,
* In order to measure the DMFT/dmft status, 1 index will be filled and applied. Intraoral examinations of the children with autism who accepted to participate in the study, who came to the Istanbul University Child Psychiatry Department for examination, will also be examined, if there is any sign or history of trauma, it will be recorded and the possible causes of the trauma, its type, time, place and accompanying clinical findings will be evaluated and risk factors that may cause trauma (overjet/overbite) will be recorded.
* While evaluating dental traumas, hard tissue and periodontal tissue injuries will be recorded separately.
* Since X-rays cannot be taken from these patients, traumas related to the root in hard tissue injuries will not be evaluated.
* The amount of overjet and overbite; will be examined using an intraoral mirror and a periodontal probe. The amount of overjet will be recorded by measuring the distance of the upper incisors to the lower incisors when the jaws are in normal closing. When measuring the amount of overbite, the amount of covering the cutting edges of the lower incisors by the cutting edges of the upper incisors will be determined when the jaws are in normal closing.
* In addition, the patients with autism who came to the Department of Child Psychiatry of Istanbul University for examination and who accepted to participate in the study, will be measured with the help of the DMFT/dmft index, whether they have a history of trauma or not, while performing intraoral examinations.

A control group will be formed from healthy children who applied to the Pediatric Dentistry Department of Istanbul University without autism, taking into account the gender and age distribution of children with autism. Then, the groups will be compared within themselves and with each other, taking into account the pandemic period and before.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Children between the ages of 3-14 who have been diagnosed with autism
* Healthy children aged 3-14 years
* Presence of parents who can adequately answer the questionnaire questions

Exclusion Criteria:

* Not willing to participate in the study
* Patients with an unclear diagnosis of autism
* Those younger than 3 years old and over 14 years old
* In case of not being able to answer the questionnaire questions from the parents or remembering the trauma history

Primary outcomes:
measure: Evaluation of the effect of the COVID-19 pandemic
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Dentistry
Study officials:
affiliation: Istanbul University
name: Arzu Pinar Erdem, Prof.
role: STUDY_DIRECTOR
References: