- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
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Cairo, Egipt
- Cairo University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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occurrence of Traumatic Dental Injury
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Risk factor of Traumatic dental injury
Ramy czasowe: 1 year
|
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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: marwa mousa mohamed, bachelor, Cairo University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Cairo University Egypt
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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