- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: marwa mousa mohamed, bachelor
- Numero di telefono: 01117237393
- Email: Marwa.Mousa@dentistry.cu.edu.eg
Backup dei contatti dello studio
- Nome: marwa mousa, bachelor
- Numero di telefono: 01117237393
- Email: Marwa.Mousa@dentistry.cu.edu.eg
Luoghi di studio
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Cairo, Egitto
- Cairo University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
occurrence of Traumatic Dental Injury
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Risk factor of Traumatic dental injury
Lasso di tempo: 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
Lasso di tempo: 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
|
1 year
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: marwa mousa mohamed, bachelor, Cairo University
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Cairo University Egypt
Piano per i dati dei singoli partecipanti (IPD)
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