- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874182
Prevalence of Dental Traumatic Injuries in A Group of Egyptian Children With Special Health Care Needs
Prevalence of Dental Traumatic Injuries in A Group of Egyptian Children With Special Health Care Needs Aging 6-14 Years : A Cross -Sectional Study
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- Parent refusal to join the study
- Patient with non specified condition
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Data collection will be performed within one year from the starting date of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Types of dental traumatic injuries
Time Frame: Data collection will be performed within one year from the starting date of the study
|
Through clinical examination when trauma is present will be recorded according to the Anderson's classification (1994) Clinical examination
|
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
|
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
|
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
|
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
|
Data collection will be performed within one year from the starting date of the study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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