- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07693322
Development of an Artificial Intelligence-Based Clinical Image Model for Detection, Classification, and Management Recommendations of Anterior Gingival Recession
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- Faculty of Dental Medicine for Girls, Al-Azhar University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sensitivity and specificity of the AI system in detecting gingival recession, compared to clinical probing measurements.
Tidsramme: Through study completion, an average of 6 months
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-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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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- Error in automated CEJ identification, compared to manual annotations.
Tidsramme: Immediately after AI analysis of the clinical images
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Immediately after AI analysis of the clinical images
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OMPDR-108-1r
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Kliniske forsøg med Gingival recessioner
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Istanbul Aydın UniversityAfsluttetGingival recession, mucogingival kirurgi | Gingival recession, generaliseret | Gingival recession, lokaliseretKalkun
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Bulent Ecevit UniversityAfsluttetGingival recession, lokaliseretTyrkiet (Türkiye)
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Ain Shams UniversityAktiv, ikke rekrutterendeGingival recession, lokaliseretEgypten
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Universidade do PortoRegedent AG, ZürichIkke rekrutterer endnuGingival recession, mucogingival kirurgiPortugal
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Dokuz Eylul UniversityAktiv, ikke rekrutterendeGingival recession, mucogingival kirurgi | Gingival recessionerTyrkiet (Türkiye)
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Minia UniversityIkke rekrutterer endnuGingival sygdomme | Gingival recession, lokaliseret | Recession, Gingival
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King Abdullah University HospitalJordan University of Science and Technology; Deanship of Scientific Research...Aktiv, ikke rekrutterendeGingival recession, mucogingival kirurgiJordan