Clinical trial NCT04235543: Occurrence of Traumatic Dental Injury in a Group of Egyptian Autistic Children Compared to Normal Children: (A Cohort Study)
Official title: Occurrence of Traumatic Dental Injury in a Group of Egyptian Autistic Children Compared to Normal Children: (A Cohort Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Dental Injury
Autism Spectrum Disorder
Dental Trauma
Keywords: Autism
traumatized teeth in autistic children
occurrence of dental trauma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyption children aged 6 to 12 years old Study group will be recruited from Abbaseya Mental Health Hospital and Advance Center For Handicapped and Autistic Children.

Control group will be recruited from Diagnosis Clinic of Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry Cairo University.

A selected sample will be used to select the sample for the study group and age- and gender-matched control group.

The investigator will make an interview with the Parents of both groups, and will explain to the parents the aim of the study without any guiding to prevent any information bias may occur, then they will be assigned Informed consent, children whose parents agreed to participate in the study were recruited.

Brief summary: The aim of the study is to assess the occurrence of traumatic dental Injury in a group of Egyptian Autistic Children compared to normal children.

Population: Egyptian children Exposure: Autistic children. Control: Normal children. Outcome: Primary Outcome: occurence of Traumatic injury. Secondary Outcome: Risk factor, Oral habits.

Detailed description: This study is a cohort study, the study group compromise a group of children with ASD, the control group compromise a group of normal children.

Study group will be recruited from Abbaseya Mental Health Hospital and Advance Center For Handicapped and Autistic Children.

Control group will be recruited from Diagnosis Clinic of Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry Cairo University.

The investigator will make an interview with the Parents of both groups to fill the A questionnaire (taken from different articles, modified by the investigator to accommodate the aims of the study.) then they will be assigned Informed consent, children whose parents agreed to participate in the study were recruited.

Inclusion criteria:

* Autistic and normal children.
* children aged from 6 to 12 years old irrespective of sex.

Exclusion criteria:

* Behavior of the child is inadequate.
* Children with dental structural defect.
* parents that refused to give informed consent.

Eligibility criteria: Inclusion Criteria:

* Autistic and normal children.
* children aged from 6 to 12 years old irrespective of sex.

Exclusion Criteria:

* Behavior of the child is inadequate.
* Children with dental structural defect.
* parents that refused to give informed consent.

Primary outcomes:
measure: occurrence of Traumatic Dental Injury
timeFrame: 1 year
Secondary outcomes:
measure: Risk factor of Traumatic dental injury
timeFrame: 1 year
measure: oral habits that contribute to TDI
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: marwa mousa mohamed, bachelor
role: PRINCIPAL_INVESTIGATOR
References: