NCT07693322

Brief Summary

This study aims to develop and evaluate an artificial intelligence-based clinical image model for the detection, classification, and management recommendations of anterior gingival recession. The study will utilize clinical images of patients presenting with gingival recession to train and validate a machine learning model capable of accurately identifying and classifying the condition according to established clinical criteria. In addition, the model will provide preliminary treatment recommendations based on the severity and type of recession. This is a diagnostic and model-development study designed to support clinicians in improving the accuracy and consistency of diagnosis and treatment planning for gingival recession in the anterior region.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

June 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

June 30, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of the AI system in detecting gingival recession, compared to clinical probing measurements.

    -Primary Outcome 1 Outcome Measure: Sensitivity and specificity of the AI system for detecting gingival recession compared with clinical probing measurements. Primary Outcome 2 Outcome Measure: Agreement between the AI system and expert clinicians in classifying gingival recession according to the Cairo classification, assessed using Cohen's kappa coefficient.

    Through study completion, an average of 6 months

Secondary Outcomes (1)

  • - Error in automated CEJ identification, compared to manual annotations.

    Immediately after AI analysis of the clinical images

Study Arms (1)

Gingival Recession Patients

This group consists of patients presenting with anterior gingival recession. Clinical intraoral images will be collected from eligible participants and used for the development and validation of an artificial intelligence-based classification model. The dataset includes cases with varying degrees and types of gingival recession according to established clinical classification criteria. No therapeutic intervention will be performed as part of the study, and all images will be analyzed for diagnostic and classification purposes only.

Diagnostic Test: Artificial Intelligence-Based Clinical Image Analysis Model

Interventions

An artificial intelligence-based clinical image model will be developed and evaluated using standardized clinical photographs of anterior teeth presenting with gingival recession. The model will be trained to detect the presence of gingival recession, classify lesions according to the Cairo classification system (RT1, RT2, and RT3), and generate preliminary management recommendations based on the identified classification. The system's performance will be assessed by comparing its diagnostic and classification outputs with expert clinical assessments.

Gingival Recession Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients presenting with gingival recession affecting anterior teeth and attending the outpatient clinics of the Faculty of Dental Medicine for Girls, Al-Azhar University. Participants with clinically visible anterior gingival recession and adequate clinical photographs suitable for image analysis will be included in the study.

You may qualify if:

  • Patients aged 18 years or older
  • Presence of at least one anterior tooth exhibiting gingival recession classified according to the Cairo classification system (RT1, RT2, or RT3). - The gingival margin must be clearly visible.
  • High-quality images (good focus, lighting, and resolution) are required.
  • Clinically visible and intact cementoenamel junction (CEJ).

You may not qualify if:

  • Presence of cervical restorations or fixed prostheses that interfere with CEJ identification.
  • Patients undergoing active orthodontic treatment.
  • Pregnant individuals, due to hormonal changes affecting gingival tissues.
  • Images with poor photographic quality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Candidate

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 9, 2026

Study Start

June 15, 2025

Primary Completion

January 15, 2026

Study Completion

April 15, 2026

Last Updated

July 9, 2026

Record last verified: 2026-07

Locations