NCT05070676

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.

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
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

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

September 14, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 14, 2021

Last Update Submit

October 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    3 monthes

Study Arms (1)

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

EXPERIMENTAL
Diagnostic Test: newly developed mobile application

Interventions

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

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

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: A newly developed mobile application will be developed to help pedodontists in orthodontic diagnosis, and treatment of dentoalveolar, or skeletal deformations
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 7, 2021

Study Start

December 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

October 7, 2021

Record last verified: 2021-09