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- Klinische proef NCT04235543
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Cairo, Egypte
- Cairo University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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autistic children aged 6:12 years
show the occurrance of traumatic dental injury compared to normal children
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normal children aged 6:12 years
show the occurrance of traumatic dental injury
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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occurrence of Traumatic Dental Injury
Tijdsspanne: 1 year
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Risk factor of Traumatic dental injury
Tijdsspanne: 1 year
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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
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oral habits that contribute to TDI
Tijdsspanne: 1 year
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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
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1 year
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: marwa mousa mohamed, bachelor, Cairo University
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Cairo University Egypt
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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