Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT07133867
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:
NCT07133867
Study Brief:
Protocol Section:
NCT07133867