- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07689552
Deep Learning-Based Measurement of Keratinized Gingiva Width Using Smartphone-Acquired Clinical Images
A Deep Learning-Based Analytical Framework for Detection, Quantification, and Quality Assessment of Keratinized Gingival Tissues in Clinical Examination Images
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This observational diagnostic validation study was conducted to develop and evaluate an artificial intelligence-based system for automated assessment of keratinized gingiva width (KGW) using smartphone-acquired intraoral clinical photographs.
Standardized intraoral images were collected from eligible participants following predefined inclusion and exclusion criteria. All images were captured using a smartphone under standardized clinical conditions to ensure uniformity in lighting, angulation, and image quality. Clinical measurements of keratinized gingiva width were independently performed by two calibrated expert examiners, serving as the reference (ground truth) standard.
A deep learning-based model was trained to segment and measure the keratinized gingival tissue from clinical images. The predicted measurements generated by the AI system were compared against the expert clinical measurements to evaluate model performance.
The performance of the system was assessed using multiple evaluation metrics, including accuracy, Dice similarity coefficient, Intersection over Union (IoU), precision, recall, and F1-score. Inter-examiner reliability between experts was also considered to ensure consistency of the reference standard.
The study aims to demonstrate the feasibility of integrating artificial intelligence into periodontal diagnostics, specifically for objective and reproducible measurement of keratinized gingiva width. The proposed system may contribute to reducing inter-operator variability and improving clinical efficiency in periodontal assessment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11754
- Faculty of Dental Medicine for Girls, Al-Azhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years or older.
Patients with varying periodontal conditions thealthy. gingivitis, periodontitie.
Patients willing to provide adormed consent.
Exclusion Criteria:
- Patients with a history of periodontal surgery within the past six montie
Patients withsystemic conditions affecting oraltissue eg. diabetes.
Very poor quality intra oral image.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants Undergoing Keratinized Gingiva Assessment
Participants whose smartphone-acquired intraoral clinical photographs were used for assessment of keratinized gingiva width.
Clinical measurements performed by expert examiners served as the reference standard for validation of the artificial intelligence model.
|
Analysis of smartphone-acquired intraoral photographs using a deep learning model for automated measurement of keratinized gingiva width.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of Artificial Intelligence-Based Keratinized Gingiva Width Measurement
Time Frame: Baseline (single study visit)
|
Evaluation of the agreement between keratinized gingiva width measurements generated by the artificial intelligence model and reference measurements obtained by calibrated examiners using smartphone-acquired intraoral clinical photographs at the baseline clinical visit.
|
Baseline (single study visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMPDR 108-1q
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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