- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07693322
Development of an Artificial Intelligence-Based Clinical Image Model for Detection, Classification, and Management Recommendations of Anterior Gingival Recession
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed to develop and validate an artificial intelligence (AI)-based clinical image analysis model for the detection, classification, and management recommendation of anterior gingival recession. Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, which may lead to aesthetic concerns, dentinal hypersensitivity, and increased risk of root caries.
Clinical intraoral images of patients presenting with anterior gingival recession will be collected following standardized imaging protocols. The dataset will be used to train, validate, and test a machine learning model capable of identifying the presence of gingival recession and classifying its severity and/or type according to established periodontal classification systems.
The AI model will also be designed to generate preliminary management recommendations based on the detected class, supporting clinical decision-making. Model performance will be evaluated using standard metrics such as accuracy, sensitivity, specificity, precision, recall, and area under the receiver operating characteristic curve (AUC-ROC).
The study is observational in nature with a diagnostic and model-development component. All patient data will be anonymized to ensure confidentiality, and ethical approval will be obtained prior to data collection. The final output is intended to support clinicians in improving diagnostic consistency and treatment planning efficiency for anterior gingival recession.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- 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
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity and specificity of the AI system in detecting gingival recession, compared to clinical probing measurements.
Time Frame: Through study completion, an average of 6 months
|
-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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
- Error in automated CEJ identification, compared to manual annotations.
Time Frame: Immediately after AI analysis of the clinical images
|
|
Immediately after AI analysis of the clinical images
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMPDR-108-1r
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Gingival Recessions
-
Postgraduate Institute of Dental Sciences RohtakNot yet recruiting
-
Dokuz Eylul UniversityActive, not recruitingGingival Recession, Mucogingival Surgery | Gingival RecessionsTurkey (Türkiye)
-
Bilecik Seyh Edebali UniversitesiNecmettin Erbakan UniversityCompletedNon Carious Cervical Lesion | Gingival RecessionsTurkey (Türkiye)
-
Necmettin Erbakan UniversityCompleted
-
Yuzuncu Yıl UniversityCompleted
-
Tanta UniversityActive, not recruitingGingival RecessionsEgypt
-
University Hospital, GhentMediplus Ltd UKRecruitingGingival Recession, Mucogingival Surgery | Gingival Recession, Localized | Gingival Recession, Plastic Surgery | Gingival RecessionsBelgium
-
G. d'Annunzio UniversityNot yet recruitingGingival Recession, Mucogingival Surgery | Suture | Gingival RecessionsItaly
-
University Hospital, GhentRecruitingGingival Recession, Mucogingival Surgery | Gingival Recession, Generalized | Gingival Recession, Localized | Gingival Recession, Plastic Surgery | Gingival Recessions | Gingival Recession Generalized Moderate | Gingival Recession Localized ModerateBelgium
Clinical Trials on Artificial Intelligence-Based Clinical Image Analysis Model
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingCancer | Lymphatic MetastasisChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCompleted
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCompletedProstatic Neoplasms | Lymphatic MetastasisChina
-
Cairo UniversityRecruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingProstatic Neoplasms, Castration-ResistantChina
-
Xiangya Hospital of Central South UniversityEnrolling by invitationProstate Cancer MetastaticChina
-
Qun ZhaoNanjing University School of Medicine; Renmin Hospital of Wuhan University; Baoding... and other collaboratorsEnrolling by invitationLymph Node Metastasis | Gastric Cancer Adenocarcinoma Metastatic | Artificial Intelligence (AI) in DiagnosisChina
-
Hasanuddin UniversityChulalongkorn UniversityRecruitingOvarian Cancer | Endometrial Hyperplasia | Endometrial CancerIndonesia
-
Cairo UniversityFuture University in EgyptRecruitingArtificial Intelligence | Open BiteEgypt
-
Zhejiang Provincial People's HospitalThe Affiliated Hospital of Qingdao University; Women's Hospital School Of Medicine... and other collaboratorsNot yet recruitingOvarian Neoplasms | Adnexal Mass