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

2 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

155

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Cairo, Egitto, 1245
        • Msa University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: OTHER
  • Prospettive temporali: PROSPECTIVE

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Accuracy and Success of AI-Based Tooth Segmentation
Lasso di tempo: 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 .

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tooth Segmentation Success Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: Dina AA Ragab, Ortho master, msa university

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 marzo 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

15 marzo 2027

Date di iscrizione allo studio

Primo inviato

8 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 novembre 2026

Primo Inserito (Effettivo)

5 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MSA university REC-D 7153-6
  • self funding (Altro numero di sovvenzione/finanziamento: by the investigator)
  • Ethical approval number (Identificatore di registro: REC-D 7153-6)
  • REC-D 7153-6 (Altro identificatore: Ethical approval MSA university)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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