NCT06992908

Brief Summary

This study evaluated a specially designed AI model developed by a programmer using x-ray readings and corresponding treatment decisions from 70% of the cases (either orthodontic treatment only or orthodontic treatment with surgery). For the evaluation, we will use the remaining 30% of cases. "Subsequently, to assess its performance, the model was tested on the remaining 30% of cases. The programmer provided only the X-ray readings as input. The AI model was then tasked with classifying.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

April 24, 2025

Last Update Submit

May 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy of diagnostic test

    In this study, the investigators have only one outcome, which is the accuracy of a diagnostic test. This test is based on the comparison of the results of machine learning decisions with a conventional method, which is an expert orthodontist's decision. Accuracy = (true positives + true negatives) / (total) A true positive will be the correct prediction of camouflage. A true negative will be the correct prediction of orthognathic surgery. Total means the total test set cases. All cases are randomly distributed. The investigators use the skeletal and dental cephalometrical parameters , some of which are angles measured by degrees, and others are linear measurements measured by millimeters. SNA SNB ANB SN/PP SN/MP Maxillary-mandibular plane angle Anterior facial height Posterior facial height Jarabak ratio Gonial angle Lower anterior facial height Open bite Maxillary anterior teeth inclination Mandibular anterior teeth inclination

    through study completion, an average of 1 year".

Study Arms (2)

Group 1: MLG acts as learning group.

Cephalometric readings parameters of cases with their decisions will be used in this group for training the machine to be able to make a decision.

Group 2: TG acts as a test group

The programmer will put parameters as input and then ask the AI model to decide on an output of the model, either camouflage or surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult anterior skeletal open bite patients with at least 3mm opening.

You may qualify if:

  • Moderate to severe Adult patients with anterior skeletal open bite (at least 3mm opening)
  • Completed their treatment successfully.
  • Well-documented cases with comprehensive preoperative and postoperative lateral cephalometric x-rays were considered.

You may not qualify if:

  • Patient below 18 years.
  • Improperly finished orthodontic treatment.
  • Incomplete documentation.
  • cleft lip and palate patient, patient with syndromes.
  • Dental open bite.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 11251, Egypt

Location

MeSH Terms

Conditions

Open Bite

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Dina Osman, Associate Professor

    supervisor

    STUDY DIRECTOR
  • Mostafa El-Dawlatly, Associate Professor

    supervisor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's student.

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 28, 2025

Study Start

May 12, 2024

Primary Completion

January 15, 2025

Study Completion

March 15, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations