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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03874182
Other study ID # 1.2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2019
Est. completion date July 2020

Study information

Verified date March 2019
Source Cairo University
Contact Sara Refaat, master
Phone 00201003316825
Email sara_refaat@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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, causes, and possible risk factors and treatment sought.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 763
Est. completion date July 2020
Est. primary completion date May 2020
Accepts healthy volunteers
Gender All
Age group 6 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Data collection will be performed within one year from the starting date of the study
Secondary Types of dental traumatic injuries 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
Secondary 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 Data collection will be performed within one year from the starting date of the study
Secondary 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 Data collection will be performed within one year from the starting date of the study
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