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CompletedNCT06992908AIASOBPUpdated May 28, 2025

Reliability of Artificial Intelligence for Treatment Decision for Adult Skeletal Open Bite Patients

An observational study in Openbite and Artifical Intelligence, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
53
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In this study, all patients were treated completely with a well-finished result by expert orthodontists. This study evaluates whether an artificial intelligence (AI) model can enhance treatment decisions for adult skeletal open bite cases by predicting the optimal intervention, either orthognathic surgery or camouflage, using cephalometric readings as input data.

First, a total of 53 cases were analyzed, which were divided into two groups:

70% were allocated to the machine learning group (MLG), while the remaining 30% constituted the test group (TG). Cephalometric analysis for all patients was performed using Dolphin Imaging 11.5 Premium software, along with determining the appropriate treatment decision, either camouflage or orthognathic surgery.

The data obtained from MLG serves as training data for the AI model to classify cases based on their cephalometric data, whether for camouflage or orthognathic surgery. The input data consisted of cephalometric readings along with a decision.

Second, after machine learning, validation takes place to examine the ability of the machine to make decisions through some cases from MLG.

The third step will evaluate the machine's ability to accurately determine case decisions based on cephalometric readings. The results produced by the machine will be compared to the actual decisions made, as all these cases were treated under the supervision of orthodontic professors.

02

Conditions studied

  • Openbite
  • Artifical Intelligence

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03

In context

Open Bite

34 studies on the registry are indexed under Open Bite; 8 are open to participants now.

Browse Open Bite studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patient below 18 years.
  • Improperly finished orthodontic treatment.
  • Incomplete documentation.
  • cleft lip and palate patient, patient with syndromes.
  • Dental open bite.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
53 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: through study completion, an average of 1 year".

07

Study locations

1 site
  • Faculty of Dentistry, Cairo University
    Cairo, 11251, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06992908
Lead sponsor
Cairo University
Responsible party
Marwa Saeed Abdullah Saeed Badyah (Master's student., Cairo University) — Principal investigator
First posted
May 28, 2025
Start date
May 12, 2024
Primary completion
Jan 15, 2025
Completion
Mar 15, 2025
Last update
May 28, 2025

Study contacts

Dina Osman, Associate Professor
study director · supervisor
Mostafa El-Dawlatly, Associate Professor
study director · supervisor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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