Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05197634 |
| Other study ID # |
2021/49 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 6, 2021 |
| Est. completion date |
August 5, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
