NCT06002373

Brief Summary

The study titled "Reliability Of Artificial Intelligence for Treatment Decision Recommendation of Adult Skeletal Class III Patients" aims to assess the accuracy and dependability of artificial intelligence (AI) in providing treatment decision recommendations for adult patients with skeletal Class III malocclusion. Skeletal Class III malocclusion is characterized by an underdeveloped upper jaw or an overdeveloped lower jaw, leading to facial and dental irregularities. The study focuses on evaluating whether AI-based recommendations can reliably guide orthodontic treatment planning for this specific patient group. This diagnostic test accuracy study involves collecting a diverse dataset of adult patients diagnosed with skeletal Class III malocclusion. AI algorithms will be trained on this dataset using various clinical and radiographic parameters to learn patterns and make treatment recommendations. The study will then compare the AI-generated treatment recommendations to those provided by experienced orthodontists. Key aspects of the study include: AI Reliability: The primary objective is to assess how consistently and accurately the AI system can recommend appropriate treatment decisions for adult skeletal Class III patients. Diagnostic Test Accuracy: The study will determine the sensitivity, specificity, positive predictive value, and negative predictive value of the AI-generated treatment recommendations. This analysis will highlight the AI's ability to correctly identify patients who require specific treatment interventions. Clinical Validity: Researchers will investigate whether the AI recommendations align with the decisions made by experienced orthodontists. This assessment is crucial to establish the AI system's clinical applicability. Potential Benefits: If the AI system proves reliable and accurate, it could offer a time-efficient and standardized method for treatment decision support, aiding orthodontists in providing personalized care to adult skeletal Class III patients. By conducting this study, researchers aim to contribute to the advancement of AI-assisted medical decision-making within the field of orthodontics. Successful outcomes would have the potential to revolutionize treatment planning processes, improve patient outcomes, and provide a valuable tool for orthodontists to make informed treatment decisions for adult skeletal Class III patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 13, 2023

Last Update Submit

August 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity

    the difference in sensitivity and specificity between the treatment decisions taken by the clinicians in comparison to those provided by the artificial intelligence software

    1 month

Eligibility Criteria

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

Adult patients with skeletal Class III malocclusion

You may qualify if:

  • Skeletally mature patients with CVMI 6.
  • Skeletal class III patients
  • No congenital deformity, syndrome, or cleft.
  • No previous surgical intervention
  • No mandibular transverse functional shift.
  • Normal overjet, overbite after completion of treatment.
  • Patients with well finished occlusion.
  • Patients who have achieved adequate functional and aesthetic results at the end of their treatment.
  • Good quality initial and final lateral cephalometric radiographs.
  • No sex predilection.

You may not qualify if:

  • Adolescents and skeletally immature patients.
  • Patients with pseudo class III.
  • Syndromic patients.
  • Patients with facial deformity at the naso-maxillary complex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

MucopolysaccharidosesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Maha AM Swelam, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 21, 2023

Study Start

May 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations