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NCT05031039 Clinical Trial

Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity

Cleft Lip and Palate Clinical Trial

Official title:
Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity: A Cross-Sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05031039
Other study ID # 14422018441165
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2021
Est. completion date August 2022

Study information
Verified date August 2021
Source Cairo University
Contact omima khaled salah, B.D.S 2014
Phone 01097494295
Email omima.salah@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this research is to evaluate the skeletal and dental maturation of cleft lip and palate patients in a sample of Egyptian population using the CVM as indicator for the skeletal maturation and the Demirjian method as indicator for the dental one when compared to a group of Egyptian non-CLP subjects of the same age.

Description:

Chronological age (CA) is not considered an accurate method for assessing the stage of physical or growth development of an individual in childhood or adolescence. For that reason, skeletal and dental maturation can be used in order to examine the rate of physical maturation of the population. Cervical vertebral maturation (CVM) method uses lateral cephalometric radiography to evaluate skeletal maturity. It is considered the preferable method due to its advantage of avoiding unnecessary extra radiation. The CVM method developed by Baccetti et al. (2005) depends on the morphology of the three cervical vertebrae (C2, C3, and C4), which divided skeletal growth into six stages of based on the morphology of the previously mentioned cervical vertebrae. The Demirjian method is considered as one of the most worldwide used method for assessment of the dental maturation due to its reliability. It depends on panoramic x-rays through which the dental developmental stage of 7 lower left teeth appears, and according to the gender of the patient the sum of values of the teeth will be transform to age through the standard tables of Carmen M. Nolla; 1960.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 250
Est. completion date August 2022
Est. primary completion date June 2022
Accepts healthy volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: (1) Subjects with non-syndromic CLP aged 6-18 years. (2) Subjects with no CLP deformity, aged 6-18 years. (4) Patients having complete records comprising dental/medical history and a lateral cephalometric and panoramic radiograph. (5) No congenitally missing teeth in the mandible. (6) No previous history of trauma to the face, neck. Exclusion Criteria: - Radiographs of poor quality. - Any growth or hereditary or systematic diseases or syndromes - Any trauma or fracture of the jaw that might have affected the normal growth of permanent dentition.

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 dental age Dental age will be evaluated by the Demirjian method 5 months
Secondary skeletal age skeletal age will be measured using the cervical vertebral method that was modified by Baccetti 2005 5 months
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