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

August 27, 2021 updated by: omima khaled salah, orthodontist, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Egyptian subjects with Cleft Lip and Palate Deformity

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Female Egyptian subjects with Cleft Lip and Palate Deformity
Egyptians females that have unilateral or bilateral cleft lip and palate deformity
Male Egyptian subjects with Cleft Lip and Palate Deformity
Egyptians males that have unilateral or bilateral cleft lip and palate deformity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dental age
Time Frame: 5 months
Dental age will be evaluated by the Demirjian method
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletal age
Time Frame: 5 months
skeletal age will be measured using the cervical vertebral method that was modified by Baccetti 2005
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14422018441165

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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