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Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software (AI-MAS)

2026年11月2日 更新者:Dina ahmed

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.

調査の概要

状態

積極的、募集していない

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

155

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:OTHER
  • 時間の展望:PROSPECTIVE

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Accuracy and Success of AI-Based Tooth Segmentation
時間枠:Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .

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 .

二次結果の測定

結果測定
メジャーの説明
時間枠
Tooth Segmentation Success Rate
時間枠:Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .

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 .
Frequency and Types of Segmentation Errors
時間枠:Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .

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 .
Time Efficiency of AI-Based Versus Manual Segmentation
時間枠: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

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Dina AA Ragab, Ortho master、msa university

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月15日

一次修了 (推定)

2027年1月1日

研究の完了 (推定)

2027年3月15日

試験登録日

最初に提出

2026年10月8日

QC基準を満たした最初の提出物

2026年11月2日

最初の投稿 (実際)

2026年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • MSA university REC-D 7153-6
  • self funding (その他の助成金/資金番号:by the investigator)
  • Ethical approval number (レジストリ識別子:REC-D 7153-6)
  • REC-D 7153-6 (その他の識別子:Ethical approval MSA university)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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