NCT05031039

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

August 20, 2021

Last Update Submit

August 27, 2021

Conditions

Cleft Lip and Palate

Keywords

skeletal & dental maturational stages

Outcome Measures

Primary Outcomes (1)

  • dental age

    Dental age will be evaluated by the Demirjian method

    5 months

Secondary Outcomes (1)

  • skeletal age

    5 months

Study Arms (2)

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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Egyptian subjects with Cleft Lip and Palate Deformity

You may qualify if:

  • (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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

omima khaled salah, B.D.S 2014

CONTACT

01097494295omima.salah@dentistry.cu.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master student

Study Record Dates

First Submitted

August 20, 2021

First Posted

September 1, 2021

Study Start

September 1, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

September 1, 2021

Record last verified: 2021-08