Traumatic Dental InjuryNCT04235543
Occurrence of Traumatic Dental Injury in a Group of Egyptian Autistic Children Compared to Normal Children: (A Cohort Study)
An observational study of Traumatic Dental Injury and Autism Spectrum Disorder, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Dental Injury, Autism Spectrum Disorder, Dental Trauma
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Autistic and normal children.
- children aged from 6 to 12 years old irrespective of sex.
Who cannot join
- Behavior of the child is inadequate.
- Children with dental structural defect.
- parents that refused to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Keywords
- Autism, traumatized teeth in autistic children, occurrence of dental trauma
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Dental InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa mousa mohamed borham, Cairo University
- Investigators
- marwa mousa mohamed, bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235543
- Sponsor's protocol ID
- Cairo University Egypt
- Status last verified
- Mar 2020
- First submitted
- 16 Jan 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Traumatic Dental Injury in a Group of Egyptian Autistic Children Compared to Normal Children: (A Cohort Study)
- ClinicalTrials.gov ID
- NCT04235543
- Acronym / sponsor ID
- Cairo University Egypt
- Keywords
- Autism, traumatized teeth in autistic children, occurrence of dental trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Autistic and normal children.
- children aged from 6 to 12 years old irrespective of sex.
Key exclusion criteria (3 listed)
- Behavior of the child is inadequate.
- Children with dental structural defect.
- parents that refused to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of Traumatic Dental Injury
Time frame: 1 year
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.
2 secondary outcomes
Risk factor of Traumatic dental injury
Time frame: 1 year
oral habits that contribute to TDI
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marwa mousa mohamed, bachelor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Dental Injury and Autism Spectrum Disorder, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marwa mousa mohamed, bachelor (01117237393, Marwa.Mousa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of Traumatic Dental Injury (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.