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Accuracy of a Newly Developed Mobile Application Versus the Conventional Method of Cephalometric Analysis in the Diagnosis of Dental and Skeletal Deformities Among Pre-adolescent Patients

Primary Purpose

Mobile Application, Cephalometric Analysis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
newly developed mobile application
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mobile Application

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Digital Lateral cephalometric radiographs of pre-adolescent patients (8-13) years old.
  2. Cephalogram of good quality with all landmarks clearly visible
  3. Presence of central incisors and first molars on cephalogram
  4. Cephalogram with teeth in maximum intercuspation

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lateral cephalometric radiographs of pre-adolescent patients (8-13) years old.

    Arm Description

    Outcomes

    Primary Outcome Measures

    The Accuracy of the newly developed mobile application versus the conventional method of cephalometric analysis in the diagnosis
    The accuracy of the mobile application will be measured based on cephalometric analysis angles( by degrees) of Egyptian people according to Soliman SA. PHD thesis 1988

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2021
    Last Updated
    October 6, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05070676
    Brief Title
    Accuracy of a Newly Developed Mobile Application Versus the Conventional Method of Cephalometric Analysis in the Diagnosis of Dental and Skeletal Deformities Among Pre-adolescent Patients
    Official Title
    Accuracy of a Newly Developed Mobile Application Versus the Conventional Method of Cephalometric Analysis in the Diagnosis of Dental and Skeletal Deformities Among Pre-adolescent Patients: A Diagnostic Accuracy Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the accuracy of a newly developed mobile application versus the conventional method of cephalometric analysis in the diagnosis of dental and skeletal deformities among pre-adolescent patients.
    Detailed Description
    A mobile application will be developed to help pedodontists in orthodontic diagnosis, and treatment of dentoalveolar, or skeletal deformations ,The mobile application will provide quick cephalometric analysis and therefore, offers rapid and accurate case diagnosis, reduces errors in tracing, measurement, and identification of the landmark. Reference test: Cephalometric analysis by the conventional method -Trial design: Diagnostic accuracy study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mobile Application, Cephalometric Analysis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A newly developed mobile application will be developed to help pedodontists in orthodontic diagnosis, and treatment of dentoalveolar, or skeletal deformations
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    17 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lateral cephalometric radiographs of pre-adolescent patients (8-13) years old.
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    newly developed mobile application
    Intervention Description
    The application will be developed in native Android, using Java (backend) and XML (front-end) as the programming language. The program of choice will be Android Studio®, YouTube® (video reproduction) and Firebase® (database) will be used as external APIs (Application Programming Interfaces). The layout of the application will be developed using: Adobe Illustrator® software. The logo, brand, objects, and shapes of the mobile application will be designed to enable to resize of the images without any loss of quality, due to the wide range of scales available in current smartphones
    Primary Outcome Measure Information:
    Title
    The Accuracy of the newly developed mobile application versus the conventional method of cephalometric analysis in the diagnosis
    Description
    The accuracy of the mobile application will be measured based on cephalometric analysis angles( by degrees) of Egyptian people according to Soliman SA. PHD thesis 1988
    Time Frame
    3 monthes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Digital Lateral cephalometric radiographs of pre-adolescent patients (8-13) years old. Cephalogram of good quality with all landmarks clearly visible Presence of central incisors and first molars on cephalogram Cephalogram with teeth in maximum intercuspation Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    Accuracy of a Newly Developed Mobile Application Versus the Conventional Method of Cephalometric Analysis in the Diagnosis of Dental and Skeletal Deformities Among Pre-adolescent Patients

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