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

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder; Dental Trauma; Traumatic Dental Injury

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: marwa mousa mohamed, bachelor; Phone Number: 01117237393; Email: Marwa.Mousa@dentistry.cu.edu.eg
• Study Contact Backup: Name: marwa mousa, bachelor; Phone Number: 01117237393; Email: Marwa.Mousa@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
autistic children aged 6:12 years; show the occurrance of traumatic dental injury compared to normal children
normal children aged 6:12 years; show the occurrance of traumatic dental injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: marwa mousa mohamed, bachelor, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Autism; traumatized teeth in autistic children; occurrence of dental trauma
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Wounds and Injuries; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: Cairo University Egypt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No