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Dental CrowdingAI-MASNCT07919652

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

An observational study of Dental Crowding, run by Dina ahmed at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dental Crowding
What is being tested?
Automated tooth segmentation and manual segmentation
How many people
155 participants
Where
1 siteEgypt
Study dates
15 Mar 2026to 15 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Msa University

    Cairo, 1245

Other trials in Egypt

About this study

Official title: 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.

Read more

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.

Conditions
Dental Crowding
Being tested
Automated tooth segmentation and manual segmentation
Keywords
adult dental crowding, tooth segmentation, AI-based segmentation, automated tooth segmentation, Artificial intelligence, Manual segmentation, Digital orthodontics, Digital dental models;, Orthodontic treatment planning
Medical subject headings
Crowding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated tooth segmentation and manual segmentationDiagnostic test

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start15 Mar 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919652
Sponsor's protocol ID
MSA university REC-D 7153-6
Other IDs
self funding, Ethical approval number, REC-D 7153-6
Acronym
AI-MAS
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Crowding, run by Dina ahmed at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy and Success of AI-Based Tooth Segmentation (time frame: Baseline assessment immedialy after completion of AI-based and manual tooth segmentation of each pretreatment digital model .). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07919652, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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