Occurrence of Traumatic Dental Injury in a Group of Egyptian Autistic Children Compared to Normal Children: (A Cohort Study)

Autism Spectrum Disorder Clinical Trial

Official title:

Occurrence of Traumatic Dental Injury in a Group of Egyptian Autistic Children Compared to Normal Children: (A Cohort Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04235543
• Other study ID #: Cairo University Egypt
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: February 2021

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: marwa mousa mohamed, bachelor
• Phone: 01117237393
• Email: Marwa.Mousa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: February 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Dental Trauma
• Traumatic Dental Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of Traumatic Dental Injury	it will be measured by Questionnaire with binary outcome(yes/no) 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.; Traumatic childhood events are associated with a wide range of negative physical, psychological and adaptive outcomes over the life course and may lead to psychiatric illness. Autism is charactarized by repetitive, restricted behaviors and self-injury which make them vulnerable to traumatic dental injury unlike children without Autism.; Management of Traumatic dental injuries in autistic children poses a major challenge because these children aren't have the ability to cooperate during dental care. Therefore, prevention of TDIs in ASD children is of a great importance.	1 year
Secondary	Risk factor of Traumatic dental injury	risk factor as playing activities,level of autism may contribute to traumatic dental injury.; it will be measured by Questionnaire with binary outcome(yes/no) and scores(low/moderate/severe) 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.	1 year
Secondary	oral habits that contribute to TDI	some types of oral habits as bruxism, lip biting, thumb sucking and tongue thrusting may contribute to occurrence of traumatic dental injury Questionnaire with binary outcome(yes/no) 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	1 year