Deep Learning-Based Measurement of Keratinized Gingiva Width Using Smartphone-Acquired Clinical Images

July 7, 2026 updated by: Salma Lamloum Mohamed Mohamed, Al-Azhar University

A Deep Learning-Based Analytical Framework for Detection, Quantification, and Quality Assessment of Keratinized Gingival Tissues in Clinical Examination Images

This study aims to develop and validate an artificial intelligence-based system for automated measurement of keratinized gingiva width using smartphone-acquired intraoral clinical photographs. Standardized intraoral images will be collected and analyzed using a deep learning model, and the results will be compared with clinical measurements performed by calibrated expert examiners, which serve as the reference standard. The performance of the proposed system will be evaluated using accuracy metrics including Dice coefficient, Intersection over Union (IoU), precision, recall, and F1-score. This study seeks to support the integration of AI tools into periodontal diagnosis and clinical decision-making to improve measurement consistency and reduce inter-examiner variability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11754
        • Faculty of Dental Medicine for Girls, Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants attending the clinic of the department of Periodontologly Faculty of Dental Medicine for girls Al-Azhar university who met the study eligibility criteria and provided smartphone-acquired intraoral clinical photographs for keratinized gingiva width assessment and artificial intelligence model validation.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Artificial Intelligence-Based Keratinized Gingiva Width Assessment
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OMPDR 108-1q

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared to protect patient confidentiality and in compliance with institutional ethical guidelines. Data access is limited to the study investigators only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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