NCT07689552

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 30, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Artificial IntelligenceDeep LearningKeratinized Gingiva WidthKGWPeriodontologyClinical PhotographyImage SegmentationAutomated MeasurementPeriodontal DiagnosisDental Artificial IntelligenceComputer VisionSmartphone Imaging

Outcome Measures

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.

    Baseline (single study visit)

Study Arms (1)

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

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

Participants Undergoing Keratinized Gingiva Assessment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients aged 18 years or older.
  • Patients with varying periodontal conditions thealthy. gingivitis, periodontitie.
  • Patients willing to provide adormed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Cairo Governorate, 11754, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Candidate, Faculty of Dental Medicine for Girls, Al-Azhar University

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 8, 2026

Study Start

July 1, 2025

Primary Completion

January 9, 2026

Study Completion

March 15, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations