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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03650634
Other study ID # CEBD-CU-2018-08-16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date September 1, 2019

Study information

Verified date July 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the prevalence of erupted supernumerary teeth among a group of Egyptian children aged from 6-15 years old attending the Outpatients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.


Description:

- Clinical examination will be done for participants fulfilling the inclusion criteria after obtaining an informed consent from parents for acceptance of participation in the study after explaining the purpose of the study and the measures that will be held to the child.

- A custom made examination chart (Appendix 1) will be filled out, during face to face interview with the child and/or his parents, including: date, name, age, gender, address, medical history and previous dental treatment followed by clinical examination to detect the presence of supernumerary teeth.

- The presence of supernumerary teeth and its type and location will be recorded in the examination chart.

- Each child with supernumerary teeth will be given a letter, translated into Arabic, outlining his dental status to inform the parents about the condition and the need for treatment

Examination chart (Appendix 1 ):

Date :...................................................................

Personal information:

Name............................................. Age..........................................

Gender :.......................................... Address : ................................

Phone number : .................................................. Medical history: ......................................................... ..................................................................................

Previous dental history: ...........................................

......................................................................................

Clinical examination :

Supernumerary teeth: presence / absence Location : ........................................... Type :..................................................


Recruitment information / eligibility

Status Completed
Enrollment 604
Est. completion date September 1, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 15 Years
Eligibility Inclusion Criteria:

- Positive patient and parent acceptance for participation in the study.

- Patients who are medically free from any systemic disease.

- Children aged from 6 to 15 years old.

- Both sexes will be included.

Exclusion Criteria:

- Uncooperative children.

- Handicapped children.

- Children who refuse to participate in the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Cairo University Cairo Manial

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of supernumerary teeth Measuring device: clinical examination. Measuring unit : binary (yes or/ no ). 6 months
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