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Clinical Trials/NCT07133867
NCT07133867Active, not recruitingNot Applicable

Evaluation of Artificial Intelligence in Planning the Treatment for Cases With Missing Upper Lateral Incisors (A Diagnostic Accuracy Pilot Study)

Cairo University1 site in 1 country110 target enrollmentStarted: March 28, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
110
Locations
1
Primary Endpoint
Diagnostic Accuracy of AI in Orthodontic Treatment Planning for Missing Maxillary Lateral Incisors

Study Overview

Brief Summary

This pilot study aims to evaluate the diagnostic accuracy of artificial intelligence (AI) in orthodontic treatment planning for patients with congenitally missing upper lateral incisors. The study compares AI-generated treatment recommendations with decisions made by experienced orthodontists regarding two main treatment options: space closure and prosthetic replacement. Orthodontic records, including intraoral and extraoral photographs, panoramic radiographs, and cephalometric analyses, will be collected for each case. Two orthodontists with over 10 years of clinical experience will independently evaluate each case using a treatment decision checklist with predefined cutoff points. AI predictions will then be compared to orthodontists' consensus decisions to determine agreement rates and accuracy. The findings will provide insight into the potential role of AI in supporting complex orthodontic decision-making.

Detailed Description

Management of congenitally missing maxillary lateral incisors is a frequent clinical challenge in orthodontics, often sparking debate among practitioners regarding the optimal treatment approach. The two primary treatment modalities are orthodontic space closure, in which adjacent teeth (usually canines) are moved into the lateral incisor position, and space opening followed by prosthetic replacement, typically with dental implants or bridges. Each option has distinct advantages and limitations in terms of esthetics, occlusion, periodontal health, and long-term stability, and the decision is influenced by multiple clinical, biological, esthetic, and patient-specific factors.

Artificial intelligence (AI), particularly through machine learning algorithms, has demonstrated high accuracy in other controversial orthodontic decision-making scenarios, such as extraction vs. non-extraction treatment and surgical vs. camouflage approaches. However, its application to lateral incisor agenesis treatment planning has not been thoroughly investigated.

This pilot diagnostic accuracy study will evaluate the performance of an AI-based decision support system in recommending treatment plans for cases with missing maxillary lateral incisors. A dataset of anticipated 100 cases will be compiled, consisting of pre-treatment records including intraoral and extraoral photographs, panoramic radiographs, and cephalometric analyses. two experienced orthodontists will independently review unfinished cases and make a treatment decision-space closure, space opening with prosthetic replacement, or undecided-using a standardized cutoff-points checklist. For finished cases, both pre- and post-treatment records will be analyzed.

A consensus decision will be established when at least two orthodontists agree; if disagreement persists, a third orthodontist will finalize the decision. AI predictions will be compared with orthodontists' consensus decisions to assess diagnostic accuracy, sensitivity, specificity, and agreement rates. This study aims to explore the feasibility of integrating AI tools into complex orthodontic decision-making and to establish a foundation for larger-scale clinical trials.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients diagnosed with unilateral or bilateral congenitally missing maxillary lateral incisors (confirmed by panoramic radiograph).
  • •Availability of complete diagnostic records: intraoral photographs, extraoral photographs, cephalometric radiograph, and panoramic radiograph.
  • •Cases either finished (completed orthodontic treatment) or unfinished (under treatment).
  • •No prior prosthetic replacement for the missing lateral incisors before initial orthodontic planning.

Exclusion Criteria

  • •Patients with craniofacial syndromes or cleft lip/palate.
  • •Cases with incomplete or poor-quality diagnostic records.
  • •History of previous orthodontic treatment unrelated to the current missing lateral incisor case.
  • •Multiple missing teeth outside the upper lateral incisor region that could affect treatment planning.

Outcomes

Primary Outcomes

Diagnostic Accuracy of AI in Orthodontic Treatment Planning for Missing Maxillary Lateral Incisors

Time Frame: Within 6 months from case assessment

The percentage agreement between AI-generated treatment decisions (space closure vs. space opening) and the consensus decisions of experienced orthodontists, based on standardized case records including intraoral photographs, cephalometric radiographs, and panoramic radiographs.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Malak Mohsen Ahmed Elagramy

Master's Candidate in Orthodontics" Faculty of Oral and Dental Medicine, Cairo University

Cairo University

Study Sites (1)

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