Dental TraumaNCT03874182
Prevalence of Dental Traumatic Injuries in A Group of Egyptian Children With Special Health Care Needs
An observational study of Dental Trauma, run by Cairo University.
Trial summary
A cross-sectional descriptive study which will investigate the Prevalence of Dental Traumatic injuries in A Group of Egyptian Children with Special Health Care needs aging 6-14 years Attending Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry, Cairo University., Investigate the types… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dental Trauma
- How many people
- 763 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Jul 2020
- 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 14 years
- All sexes
- Child
Study population: This cross-sectional study included a convenient sample from all patients with special health care needs coming to pediatric dentistry and dental public health department in Cairo University.
Who may be able to join
- Age of children between 6 and 14 years old
- Both sexes.
- Patient who has one of the following conditions:
- Cerebral palsy
- Down's syndrome
- Neurobehavioral disorders such as autism spectrum disorder (ASD) and attention deficient hyperactive disorder( ADHD)
Show all 12Show fewer
- Intellectual disability and learning difficulties
- Motor difficulty
- Visual impairment
- Hearing and speech impairment
- Multiple disability : patients with more than one medical condition
- Developmental Delay and Epilepsy
Who cannot join
- Parent refusal to join the study
- Patient with non specified condition
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Dental Traumatic Injuries in A Group of Egyptian Children With Special Health Care Needs Aging 6-14 Years : A Cross -Sectional Study
A cross-sectional descriptive study which will investigate the Prevalence of Dental Traumatic injuries in A Group of Egyptian Children with Special Health Care needs aging 6-14 years Attending Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry, Cairo University., Investigate the types, causes, and possible risk factors and treatment sought.
Read the detailed description
Study Design:A Cross -sectional descriptive study design. Participant: Children with special health care needs between 6 to 14 years. Setting: Patients coming to pediatric dentistry and dental public health department in Cairo University.
All the procedures will be explained to the parents or guardians prior to the investigation.An informed consent will be signed by parents.
Method:Data for the study will be collected using an interviewer - administered questionnaire.The interviewer - administered questionnaire will be in Arabic in multiple choice form and will include:
- History of current and previous dental trauma: including place and cause of the trauma.
- Treatment sought :
If treatment was sought, the parent will be asked to indicate the type of treatment received:
- Pharmacological: prescription of pain killers, antibiotics, and tetanus injections.
- Dental: restorative, endodontic, surgical, prosthetic, and splinting.
If treatment was not sought, the parent will be asked to select one or more of the reasons for this, including the following:
- Financial: transportation, dental insurance coverage, and acceptance of insurance by dentist.
- Parental attitude: lack of trust in dentists, inability to wait for appointment, lack of dental awareness such as not knowing where to go, or the belief that the trauma was not worth seeking treatment.
- Difficulties in getting an appointment: availability of dental clinics that was willing to see the children.
The clinical examination will be carried out under artificial light of dental unit by using mirror and Goldman- Fox periodontal probe according to custom-made examination chart which is made according to Assessment of acute traumatic injuries chart (Adopted from American Academy of Pediatric Dentistry, Pediatr Dent 24 (7suppl):95-96, 2002) and consisted of:
- Child's demographic data (Personal history), past and present medical history, past dental history and history of the trauma.
- Extra oral examination and intra oral examination to detect:
- The presence/absence of dental traumatic injuries determined by direct clinical examination, when trauma is present will be recorded according to the Andreasen classification (1994) .
- Condition of the injured tooth: mobility, tenderness to percussion, and discoloration of traumatized teeth.
- Possible associated risk factors with dental traumatic injuries: overjet, overbite, lip competence, anterior crowding.
- Using Goldman -Fox periodontal probe overjet will be measured as the amount of extension of the incisal edges of upper incisors labially beyond the incisal edges of the lower incisors when the jaws are closed normally. Overbite will be measured as the amount of overlap of the incisal edges of the upper anterior teeth and the incisal edges of the lower teeth when the jaws are closed.
- Dental photographs
- Conditions
- Dental Trauma
- Keywords
- Prevalence, Dental trauma, Special health care needs children
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dental traumatic injuries in children with special health care needs
Through clinical examination to detect presence or absence of dental trauma will detect presence/absence of dental trauma
Measured: Data collection will be performed within one year from the starting date of the study
Secondary outcomes (3)
Types of dental traumatic injuries
Through clinical examination when trauma is present will be recorded according to the Anderson's classification (1994) Clinical examination
Measured: Data collection will be performed within one year from the starting date of the study
Causes of dental traumatic injuries
History of the causes of dental trauma will be obtained through an interviewer - administered questionnaire which will be in Arabic and the questions in multiple choice form
Measured: Data collection will be performed within one year from the starting date of the study
Risk factors of dental traumatic injuries
Overjet, overbite, lip competence, anterior crowding. Using Goldman -Fox periodontal probe overjet will be measured as the amount of extension of the incisal edges of upper incisors labially beyond the incisal edges of the lower incisors when the jaws are closed normally. Overbite will be measured as the amount of overlap of the incisal edges of the upper anterior teeth and the incisal edges of the lower teeth when the jaws are closed
Measured: Data collection will be performed within one year from the starting date of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TraumaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 763 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Refaat Ahmad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874182
- Sponsor's protocol ID
- 1.2
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dental Traumatic Injuries in A Group of Egyptian Children With Special Health Care Needs Aging 6-14 Years : A Cross -Sectional Study
- ClinicalTrials.gov ID
- NCT03874182
- Acronym / sponsor ID
- 1.2
- Conditions
- Dental Trauma
- Keywords
- Prevalence, Dental trauma, Special health care needs children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 763 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 14 Mar 2019 (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.
A cross-sectional descriptive study which will investigate the Prevalence of Dental Traumatic injuries in A Group of Egyptian Children with Special Health Care needs aging 6-14 years Attending Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry, Cairo University., Investigate the types, causes, and possible risk factors and treatment sought.
Detailed description
Study Design:A Cross -sectional descriptive study design. Participant: Children with special health care needs between 6 to 14 years. Setting: Patients coming to pediatric dentistry and dental public health department in Cairo University.
All the procedures will be explained to the parents or guardians prior to the investigation.An informed consent will be signed by parents.
Method:Data for the study will be collected using an interviewer - administered questionnaire.The interviewer - administered questionnaire will be in Arabic in multiple choice form and will include:
- History of current and previous dental trauma: including place and cause of the trauma.
- Treatment sought :
If treatment was sought, the parent will be asked to indicate the type of treatment received:
- Pharmacological: prescription of pain killers, antibiotics, and tetanus injections.
- Dental: restorative, endodontic, surgical, prosthetic, and splinting.
If treatment was not sought, the parent will be asked to select one or more of the reasons for this, including the following:
- Financial: transportation, dental insurance coverage, and acceptance of insurance by dentist.
- Parental attitude: lack of trust in dentists, inability to wait for appointment, lack of dental awareness such as not knowing where to go, or the belief that the trauma was not worth seeking treatment.
- Difficulties in getting an appointment: availability of dental clinics that was willing to see the children.
The clinical examination will be carried out under artificial light of dental unit by using mirror and Goldman- Fox periodontal probe according to custom-made examination chart which is made according to Assessment of acute traumatic injuries chart (Adopted from American Academy of Pediatric Dentistry, Pediatr Dent 24 (7suppl):95-96, 2002) and consisted of:
- Child's demographic data (Personal history), past and present medical history, past dental history and history of the trauma.
- Extra oral examination and intra oral examination to detect:
- The presence/absence of dental traumatic injuries determined by direct clinical examination, when trauma is present will be recorded according to the Andreasen classification (1994) .
- Condition of the injured tooth: mobility, tenderness to percussion, and discoloration of traumatized teeth.
- Possible associated risk factors with dental traumatic injuries: overjet, overbite, lip competence, anterior crowding.
- Using Goldman -Fox periodontal probe overjet will be measured as the amount of extension of the incisal edges of upper incisors labially beyond the incisal edges of the lower incisors when the jaws are closed normally. Overbite will be measured as the amount of overlap of the incisal edges of the upper anterior teeth and the incisal edges of the lower teeth when the jaws are closed.
- Dental photographs
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- This cross-sectional study included a convenient sample from all patients with special health care needs coming to pediatric dentistry and dental public health department in Cairo University.
Key inclusion criteria (12 listed)
- Age of children between 6 and 14 years old
- Both sexes.
- Patient who has one of the following conditions:
Key exclusion criteria (2 listed)
- Parent refusal to join the study
- Patient with non specified condition
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
Prevalence of dental traumatic injuries in children with special health care needs
Time frame: Data collection will be performed within one year from the starting date of the study
Through clinical examination to detect presence or absence of dental trauma will detect presence/absence of dental trauma
3 secondary outcomes
Types of dental traumatic injuries
Time frame: Data collection will be performed within one year from the starting date of the study
Causes of dental traumatic injuries
Time frame: Data collection will be performed within one year from the starting date of the study
Risk factors of dental traumatic injuries
Time frame: Data collection will be performed within one year from the starting date of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Trauma, run by Cairo University.
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 12 inclusion and 2 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Sara Refaat, master (00201003316825, sara_refaat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dental traumatic injuries in children with special health care needs (time frame: Data collection will be performed within one year from the starting date of the study). 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 22 Apr 2019.