- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07919652
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software (AI-MAS)
Evaluation of Accuracy and Time Efficiency of AI-based Versus Manual Segmentation in Adult Crowding Cases Using Two Aligner Software Programs: A Diagnostic Accuracy Study
The purpose of this study is to evaluate how accurately and quickly artificial intelligence (AI) can separate individual teeth from digital dental scans of adults with dental crowding. The study will compare AI-based tooth segmentation with manual segmentation performed by experienced orthodontists.
Digital dental scans from adult patients with moderate to severe dental crowding will be analyzed. The scans will be processed using two orthodontic software programs, Archform 2.6.4.1 and Blue Sky Plan V5, which use AI to automatically identify and separate individual teeth. The same scans will also be manually segmented by experienced orthodontists.
The study will compare the results from the different methods by assessing whether the teeth are correctly identified and separated, the accuracy of tooth measurements, the types of segmentation errors, and the time required to complete the segmentation.
The study aims to determine whether AI-based segmentation can provide accurate results while reducing the time required for digital orthodontic analysis. The findings may help improve the efficiency of digital orthodontic diagnosis and treatment planning, particularly for adults with crowded teeth.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study is a prospective diagnostic accuracy study designed to evaluate the accuracy and time efficiency of artificial intelligence (AI)-based automated tooth segmentation compared with manual segmentation in adult patients with moderate to severe dental crowding.
Digital orthodontic workflows depend on accurate identification and separation of individual teeth from three-dimensional dental models. Accurate tooth segmentation is important for diagnosis, assessment of dental crowding, virtual treatment planning, clear aligner design, and evaluation of planned tooth movements. Manual segmentation is currently used as a reference method because experienced orthodontists can identify and delineate individual tooth boundaries accurately. However, manual segmentation can be time-consuming and may be affected by differences between operators, particularly in crowded dentitions where overlapping teeth, proximal contacts, unclear boundaries, and gingival margins can make tooth separation more difficult.
Recent advances in artificial intelligence have resulted in automated tooth segmentation tools that can identify and separate individual teeth from digital dental models. These systems may reduce the time required for digital orthodontic workflows; however, their performance may be affected by the complexity of the dentition. In particular, dental crowding may create areas in which tooth boundaries are difficult to distinguish, potentially resulting in deficient or excessive segmentation or failure to correctly identify individual teeth.
The present study will evaluate AI-based segmentation using two orthodontic software platforms, Archform 2.6.4.1 and Blue Sky Plan V5. Pretreatment intraoral digital scans of adult patients with dental crowding will be used. The digital scans will be obtained using a Medit i900 intraoral scanner and will be available as digital dental models in STL format. The digital models will be anonymized and coded before analysis.
For the index test, the STL models will be imported into Archform 2.6.4.1 and Blue Sky Plan V5. The AI-based segmentation functions of each software platform will be used to automatically identify and separate individual teeth. The resulting segmented models will then be evaluated for successful identification and separation of the teeth and for the quality of the generated tooth boundaries.
Manual segmentation will be performed on the same digital dental models by experienced orthodontists and will serve as the reference standard. The orthodontists will delineate the boundaries of individual teeth using the available digital segmentation tools. The manual segmentation procedure will be performed independently from the AI-generated results to minimize the possibility of influence between the index test and the reference standard.
The study will evaluate segmentation performance at the individual tooth level. A segmentation will be considered successful when the software correctly identifies the tooth and accurately delineates its margins. Segmentation will be considered unsuccessful when tooth margins are deficient or excessive, when the boundaries are incorrectly identified, or when an individual tooth cannot be correctly identified or separated.
The accuracy of AI-based segmentation will be assessed by comparing the AI-generated tooth segments with the manually segmented reference models. Mesiodistal tooth width measurements will be obtained from both AI-generated and manually segmented models. Differences between the measurements will be evaluated to identify discrepancies associated with automated segmentation. The study will also document specific segmentation errors, including deficient or excessive segmentation, tooth identification failures, proximal contact reconstruction problems, and difficulties in detecting gingival margins. Errors involving occlusal, vestibular, and lingual surfaces will also be recorded.
The study will additionally assess the time efficiency of the three segmentation approaches: AI-based segmentation using Archform 2.6.4.1, AI-based segmentation using Blue Sky Plan V5, and manual segmentation. Processing time will be recorded from the beginning of STL file import or segmentation processing until completion of the segmentation procedure. The mean time required by each method will then be compared.
To reduce assessment bias, the digital models used for evaluation will be anonymized and coded. Examiners assessing segmentation success or failure will be blinded to whether the models were produced using AI-based or manual segmentation. The order of model assessment will be randomized.
The study will focus specifically on adult dentitions with moderate to severe dental crowding, as crowding presents a clinically challenging environment for automated tooth segmentation. The study will therefore provide information not only on the overall performance of AI segmentation but also on the types of errors that may occur in crowded dentitions.
The primary purpose of the study is to evaluate the success and failure of AI-based tooth segmentation using Archform 2.6.4.1 and Blue Sky Plan V5 compared with manual segmentation. Secondary purposes include comparing the performance of the two AI-based software platforms, evaluating differences in processing time, and identifying the types of segmentation errors associated with adult dental crowding.
The results of this study may provide evidence regarding the reliability and efficiency of AI-assisted tooth segmentation in challenging orthodontic digital workflows. The findings may help determine the extent to which automated segmentation can support orthodontic diagnosis and digital treatment planning and whether manual review or correction may remain necessary when working with crowded dentitions.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Cairo, Egypt, 1245
- Msa University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The study population will consist of pretreatment intraoral digital scans from adult patients with moderate-to-severe dental crowding who require orthodontic treatment with clear aligners. The scans will include complete permanent dentition in both arches and will be of sufficient quality for accurate digital tooth segmentation. Digital scans will be obtained from orthodontic clinic databases at MSA University, Cairo, Egypt, and will be anonymized and coded before analysis. Eligible scans will be evaluated using AI-based automated tooth segmentation and manual segmentation as the reference standard.
Popis
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Availability of pretreatment intraoral digital scans with acceptable scan quality.
- Complete permanent dentition in both dental arches.
- Moderate-to-severe dental crowding, defined as a tooth size-arch length discrepancy of approximately 4-10 mm in at least one arch.
- Digital scans of sufficient quality to allow accurate visualization and segmentation of individual teeth.
Exclusion Criteria:
- Missing or supernumerary teeth.
- Large multi-unit fixed prostheses, extensive restorations, or gross caries that alter normal tooth morphology.
- Partially erupted teeth.
- Poor-quality or incomplete intraoral digital scans.
- Previous orthodontic treatment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: OTHER
- Časové perspektivy: PROSPECTIVE
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Accuracy and Success of AI-Based Tooth Segmentation
Časové okno: Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .
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The primary outcome is the accuracy and success of AI-based automated tooth segmentation compared with manual segmentation as the reference standard. Segmentation will be considered successful when all tooth margins are correctly identified and separated. Failure will be recorded when tooth margins are not correctly identified or when deficient or excessive segmentation is present. The performance of AI-based segmentation will be evaluated using the segmented tooth morphology and mesiodistal tooth width and compared with the manually segmented digital models. |
Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tooth Segmentation Success Rate
Časové okno: Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .
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Percentage of teeth successfully identified and segmented by AI-based and manual segmentation, assessed by tooth identification and surface quality (occlusal, vestibular, and lingual surfaces), including adequate segmentation and deficit or surplus errors. Results will be stratified by tooth type and crowding severity. |
Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .
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Frequency and Types of Segmentation Errors
Časové okno: Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .
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Frequency and types of segmentation errors identified during AI-based and manual tooth segmentation, including proximal contact reconstruction failures and gingival margin deficits, in adult patients with moderate-to-severe dental crowding. |
Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .
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Time Efficiency of AI-Based Versus Manual Segmentation
Časové okno: Time required to complete AI-based and manual tooth segmentation of each pretreatment digital model, recorded immediately upon completion of each segmentation procedure. The time taken for each method will be measured in minutes and compared
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Comparison of the time required to complete tooth segmentation using AI-based automated software versus manual segmentation, measured in minutes per digital model. |
Time required to complete AI-based and manual tooth segmentation of each pretreatment digital model, recorded immediately upon completion of each segmentation procedure. The time taken for each method will be measured in minutes and compared
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Dina AA Ragab, Ortho master, msa university
Publikace a užitečné odkazy
Obecné publikace
- Al-Ubaydi AS, Al-Groosh D. The Validity and Reliability of Automatic Tooth Segmentation Generated Using Artificial Intelligence. ScientificWorldJournal. 2023 Jul 18;2023:5933003. doi: 10.1155/2023/5933003. eCollection 2023.
- Cui Z, Li C, Chen N, Wei G, Chen R, Zhou Y, Shen D, Wang W. TSegNet: An efficient and accurate tooth segmentation network on 3D dental model. Med Image Anal. 2021 Apr;69:101949. doi: 10.1016/j.media.2020.101949. Epub 2020 Dec 19.
- Yacout YM, Eid FY, Tageldin MA, Kassem HE. Evaluation of the accuracy of automated tooth segmentation of intraoral scans using artificial intelligence-based software packages. Am J Orthod Dentofacial Orthop. 2024 Sep;166(3):282-291.e1. doi: 10.1016/j.ajodo.2024.05.015. Epub 2024 Jun 21.
- Im J, Kim JY, Yu HS, Lee KJ, Choi SH, Kim JH, Ahn HK, Cha JY. Accuracy and efficiency of automatic tooth segmentation in digital dental models using deep learning. Sci Rep. 2022 Jun 8;12(1):9429. doi: 10.1038/s41598-022-13595-2.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MSA university REC-D 7153-6
- self funding (Jiné číslo grantu/financování: by the investigator)
- Ethical approval number (Identifikátor registru: REC-D 7153-6)
- REC-D 7153-6 (Jiný identifikátor: Ethical approval MSA university)
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