CClinicalTrials.gg
CompletedNCT07689552Updated Jul 8, 2026

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

An observational study in Periodontal Diseases, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Periodontal Diseases

Browse trials for

Keywords

  • Artificial Intelligence
  • Deep Learning
  • Keratinized Gingiva Width
  • KGW
  • Periodontology
  • Clinical Photography
  • Image Segmentation
  • Automated Measurement
  • Periodontal Diagnosis
  • Dental Artificial Intelligence
  • Computer Vision
  • Smartphone Imaging
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Inclusion criteria

  • Patients aged 18 years or older.

Patients with varying periodontal conditions thealthy. gingivitis, periodontitie.

Patients willing to provide adormed consent.

Exclusion criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testArtificial Intelligence-Based Keratinized Gingiva Width Assessment

    Analysis of smartphone-acquired intraoral photographs using a deep learning model for automated measurement of keratinized gingiva width.

06

What researchers measure

Primary outcomes

  1. Accuracy of Artificial Intelligence-Based Keratinized Gingiva Width Measurement

    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.

    Time frame: Baseline (single study visit)

07

Study locations

1 site
  • Faculty of Dental Medicine for Girls, Al-Azhar University
    Cairo, Cairo Governorate 11754, Egypt
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07689552
Lead sponsor
Al-Azhar University
Responsible party
Salma Lamloum Mohamed Mohamed (Master's Degree Candidate, Faculty of Dental Medicine for Girls, Al-Azhar University, Al-Azhar University) — Principal investigator
First posted
Jul 8, 2026
Start date
Jul 1, 2025
Primary completion
Jan 9, 2026
Completion
Mar 15, 2026
Last update
Jul 8, 2026

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 completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion