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Active, not recruitingNCT07919652AI-MASUpdated Nov 5, 2026

Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software

An observational study in Dental Crowding, sponsored by Dina ahmed. Active, not recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Dina ahmed · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
155
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Dental Crowding

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Keywords

  • adult dental crowding
  • tooth segmentation
  • AI-based segmentation
  • automated tooth segmentation
  • Artificial intelligence
  • Manual segmentation
  • Digital orthodontics
  • Digital dental models;
  • Orthodontic treatment planning
03

In context

Crowding

88 studies on the registry are indexed under Crowding; 22 are open to participants now.

This study's enrollment of 155 is below the median of 664 across 14 observational studies indexed under Crowding.

Browse Crowding studies →

Lead sponsor

This is the only study on the registry with Dina ahmed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
155 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testAutomated tooth segmentation and manual segmentation

    AI-based automated tooth segmentation of pretreatment intraoral digital scans using two orthodontic software platforms: Archform 2.6.4.1 and Blue Sky Plan V5. The AI systems will automatically identify and separate individual teeth from digital dental models obtained from adults with moderate-to-severe dental crowding. The resulting tooth segmentation will be evaluated for segmentation success, accuracy, mesiodistal tooth measurements, and types of segmentation errors, and compared with manual tooth segmentation performed by experienced orthodontists as the reference standard. Processing time from digital scan import to completion of segmentation will also be recorded for each AI-based workflow and for manual segmentation.

06

What researchers measure

Primary outcomes

  1. Accuracy and Success of AI-Based Tooth Segmentation

    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.

    Time frame: Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .

Secondary outcomes

  1. Tooth Segmentation Success Rate

    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.

    Time frame: Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .

  2. Frequency and Types of Segmentation Errors

    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.

    Time frame: Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .

  3. Time Efficiency of AI-Based Versus Manual Segmentation

    Comparison of the time required to complete tooth segmentation using AI-based automated software versus manual segmentation, measured in minutes per digital model.

    Time frame: 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

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 37497386 ↗
  • 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. PubMed 33387908 ↗
  • 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. PubMed 38904564 ↗
  • 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. PubMed 35676524 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07919652
Lead sponsor
Dina ahmed
Collaborators
October University for Modern Sciences and Arts
Responsible party
Dina ahmed (Master's Student in Orthodontic at MSA, October University for Modern Sciences and Arts) — Sponsor-investigator
First posted
Nov 5, 2026
Start date
Mar 15, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Dina AA Ragab, Ortho master
study director · msa university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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