NCT06603233

Brief Summary

Background: Dental plaque contributes to a number of common oral conditions such as caries, gingivitis, and periodontitis. As a result, detection and management of plaque is of great importance for the oral health of individuals. The primary objectives of this study were to design a deep learning model for the detection and segmentation of plaque in young permanent teeth and to evaluate the diagnostic accuracy of the model. Methods: The dataset contains 506 dental images from 31 patients aged 8 to 13 years. Six state-of-the-art models were trained and tested using this dataset. The U-Net Transformer model was compared with three dentists for clinical applicability using 35 randomly selected images from the test set.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

June 30, 2024

Last Update Submit

September 16, 2024

Conditions

Keywords

Dental PlaqueDeep LearningAI ModelPediatric Dentistry

Outcome Measures

Primary Outcomes (2)

  • Determination of IoU and Dice Coefficient values among six state-of-the-AI models

    The IoU score, which computes the ratio between the intersection and the union of two sets, is commonly used to evaluate the accuracy of prediction on semantic segmentation. DeepLabV3+, Mask R-CNN (Detectron2), YOLOv8, U-Net, Super Vision U-net and U-Net Transformer were trained on 354 images and tested on 79 images. IoU and Dice Coefficient values were established among six state-of-the-AI models. As the IoU score increases, the prediction score increases. As the score increases, it becomes more distinctive in determining the model that gives results closest to the correct result.

    two weeks

  • Prediction scores of the dentists and U-Net Transformer on 35 test images

    The prediction scores of the three dentists and the AI model (U-Net Transformer) on 35 test images

    two weeks

Secondary Outcomes (1)

  • T-test results comparing the AI model and the three dentists

    two weeks

Study Arms (2)

Deep Learning Models Group

EXPERIMENTAL

As artificial intelligence models, DeepLabV3+, Mask R-CNN (Detectron2), YOLOv8, U-Net, Super Vision U-net and U-Net Transformer models, which are state-of-the-art in semantic segmentation, were selected.

Diagnostic Test: Deep Learning Models

The Difference Between The AI Model (U-Net Transformer) and Dentists Group

ACTIVE COMPARATOR

Using the prior knowledge (α = 0.05, β = 0.2) and an effect size of 0.61, the actual power of the comparison between the AI model (U-Net Transformer) and dentists on 34 test images is at least 80%, which is deemed sufficient. Therefore, randomly selected 35 images on the test dataset were labeled by three dentists without seeing the ground truth and were predicted by the AI model. Then, the intersection over union (IoU) score of these labeled and predicted images were calculated. The IoU score, which computes the ratio between the intersection and the union of two sets, is commonly used to evaluate the accuracy of prediction on semantic segmentation. To confirm clinical feasibility, three t-tests, which evaluates the difference between the means of two variables, were applied to IoU scores of dentists and IoU scores of the AI model and a p value \< .05 was considered statistically significant.

Diagnostic Test: The Difference Between The AI Model and Dentists Group

Interventions

The clinical feasibility of the best performing model, statistical hypothesis tests are performed that compares the predictions of the AI model with the assessments from three dentists.

Also known as: The AI Model and Dentists Group
The Difference Between The AI Model (U-Net Transformer) and Dentists Group
Deep Learning ModelsDIAGNOSTIC_TEST

DeepLabV3+, Mask R-CNN (Detectron2), YOLOv8, U-Net, Super Vision U-net and U-Net Transformer were trained on 354 images and tested on 79 images.

Also known as: The Architecture of Deep Learning Models
Deep Learning Models Group

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Anterior young permanent teeth

You may not qualify if:

  • Anterior young permanent teeth exhibiting disruptions in enamel tissue integrity such as decay
  • Hypoplasia, hypomineralization
  • Restored and prosthetically treated teeth
  • Young permanent teeth located in the posterior region
  • Primary teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banu Çiçek Tez

Istanbul, Üsküdar, Turkey (Türkiye)

Location

Related Publications (4)

  • Liu L, Xu J, Huan Y, Zou Z, Yeh SC, Zheng LR. A Smart Dental Health-IoT Platform Based on Intelligent Hardware, Deep Learning, and Mobile Terminal. IEEE J Biomed Health Inform. 2020 Mar;24(3):898-906. doi: 10.1109/JBHI.2019.2919916. Epub 2019 Jun 7.

    PMID: 31180873BACKGROUND
  • You W, Hao A, Li S, Wang Y, Xia B. Deep learning-based dental plaque detection on primary teeth: a comparison with clinical assessments. BMC Oral Health. 2020 May 13;20(1):141. doi: 10.1186/s12903-020-01114-6.

    PMID: 32404094BACKGROUND
  • Li S, Guo Y, Pang Z, Song W, Hao A, Xia B, Qin H. Automatic Dental Plaque Segmentation Based on Local-to-Global Features Fused Self-Attention Network. IEEE J Biomed Health Inform. 2022 May;26(5):2240-2251. doi: 10.1109/JBHI.2022.3141773. Epub 2022 May 5.

    PMID: 35015655BACKGROUND
  • Tez BC, Guzel Y, Kiziltan Eliacik BB, Aydin Z. Deep-Learning-Based AI-Model for Predicting Dental Plaque in the Young Permanent Teeth of Children Aged 8-13 Years. Children (Basel). 2025 Apr 7;12(4):475. doi: 10.3390/children12040475.

Related Links

MeSH Terms

Conditions

Dental PlaqueDisease

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Banu Çiçek Tez, Ph.D

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Model Details: Using the prior knowledge (α = 0.05, β = 0.2) and an effect size of 0.61, the actual power of the comparison between the AI model and dentists on 34 test images is at least 80%, which is deemed sufficient. Therefore, randomly selected 35 images on the test dataset were labeled by three dentists without seeing the ground truth and were predicted by the AI model. Then, the intersection over union (IoU) score of these labeled and predicted images were calculated. The IoU score, which computes the ratio between the intersection and the union of two sets, is commonly used to evaluate the accuracy of prediction on semantic segmentation. AI model's dental plaque predictions compared with predictions from three dentists.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 30, 2024

First Posted

September 19, 2024

Study Start

June 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations