NCT04973241

Brief Summary

Growth changes occur from the intrauterine life to senility, hard tissues like bones and teeth undergo changes with growth, a change in shape and/or fusion of ossification centers, the stability of these changes facilitate ease in estimation of age from hard tissue samples ( Bhalaji ,2006;Reddy,2006; Mohite et al.,2011). Mandibles were used for the study for two simple causes: First, there appears to be a lack of standards utilizing this element and second, this bone is often recovered mostly intact (Franklin et al.,2008) The mandible is considered the most durable facial bone ;is due to the presence of a dense layer of compact bone and therefore remains well conserved than many other bones and the only movable bone of the skull available for gender identification; is due to the morphological characteristics of mandible, and radiology plays an important role in it. It is composed of two hemi mandibles united at the midline by a vertical symphysis. Each one of them is composed of a horizontal body with a posterior vertical extension termed the ramus(ndira et al.,2012 ). Mandibular canines are found to exhibit the highest sexual dimorphism.The mean age of eruption of mandibular canines is 10.87 years, and they are the last teeth to be extracted with respect to age; so, they can be considered as the key teeth for personal identification (Khangura et al.,2011; Padmavati et al.,2011; Yuwanati et al.,2012). Measurements of the mandibular ramus tend to show higher sexual dimorphism, and variations between the sexes are mostly more marked in the mandibular ramus than in the mandibular body (Humphrey et al.,1999). Gonial angle is commonly used to determine the rotation of the mandible and to identify growth pattern, it is a common parameter used to describe orthodontic extractions or surgical treatments(Kitai et al.,2013). Several studies focused on the comparison between CBCT (Cone Beam Computed Tomography) and OPG (Orthopantomograph) for visualization of bone and teeth (Dalessandri et al.,2012 ;Savoldi et al.,2015). OPG is a very popular technique ,the most available and commonly used extra-oral radiography, its lower cost ,wide area coverage ,ease of preparation have made it an excellent choice for routine examination of many structures thus useful for research purpose does not involve the patient any additional exposure or cost(Ghosh et al.,2009 ;Sairam et al.,2016). The CBCT imaging device can obtain undistorted three-dimensional (3D) images of good quality with a low radiation dose (Yamamoto et al.,2003).

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

July 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 13, 2021

Last Update Submit

July 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparison of OPG & CBCT

    2\. Comparison of the accuracy in identification of age and sex between using digital orthopantomographs and cone beam computed tomography

    Baseline

Study Arms (2)

OPG

Radiation: OPG & CBCT

CBCT

Radiation: OPG & CBCT

Interventions

OPG & CBCTRADIATION

panoramic images , cone beam computed tomography

CBCTOPG

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

persons aged between 15 and 40 years.

You may qualify if:

  • \- 1. Panoramic radiographs and cone beam computed tomography of patients aged15-40 years.
  • \. Only patients with a documented date of birth.

You may not qualify if:

  • \. Asymmetry in OPG and CBCT images, unreadable ,unclear ,poor quality, gross pathology and magnification.
  • \. Panoramic radiographs with positioning errors which could cause distortions in the dimensions.
  • \. Hereditary facial asymmetries. 4. Images of completely edentulous patients. 5. Surgical intervention, patients with orthognathic surgeries. 6. Presence of pathologies such as fractures, impacted teeth, missing teeth, cleft lip or palate, cysts, tumors, osteomyelitis,severe osteoporosis in the mandible, periodontal lesion, and congenital craniofacial abnormalities, in the lower jaw, resorption in the mandibular arch that could affect the interpretation of radiographic image, 7. History of head trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Eman Mahmoud Metwally, Demonstrator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eman Mahmoud Metwally

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 22, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share