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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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:

  1. History of current and previous dental trauma: including place and cause of the trauma.
  2. Treatment sought :

If treatment was sought, the parent will be asked to indicate the type of treatment received:

  1. Pharmacological: prescription of pain killers, antibiotics, and tetanus injections.
  2. 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:

  1. Financial: transportation, dental insurance coverage, and acceptance of insurance by dentist.
  2. 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.
  3. 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:
  1. 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) .
  2. Condition of the injured tooth: mobility, tenderness to percussion, and discoloration of traumatized teeth.
  3. Possible associated risk factors with dental traumatic injuries: overjet, overbite, lip competence, anterior crowding.
  4. 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted14 Mar 2019
  2. Study startMay 2019 (estimated)
  3. Primary completionMay 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

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)
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

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.

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