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
About this trial
This is an interventional diagnostic trial for Mobile Application
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:
-
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
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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