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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07775365
AI-Based Prediction of Root Coverage Outcome From Intraoral Photographs
Development and Internal Validation of a Deep Learning Model Predicting the Outcome of Root Coverage Surgery From Preoperative Intraoral Photographs: A Prospective Observational Cohort Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Whether an exposed root surface can be completely covered is the central question in planning mucogingival surgery. The Cairo classification is the current diagnostic standard for that judgement, but assignment of the recession type varies between examiners and prediction of the individual surgical outcome remains largely subjective. In this cohort, consecutive systemically healthy adults with Cairo RT1,RT2 or RT3 gingival recessions are treated by a single operator with a coronally advanced flap combined with a subepithelial connective tissue graft. Recession depth, keratinised tissue width and gingival thickness are recorded at baseline and at three and six months.
Standardised intraoral photographs are obtained at each time point under fixed conditions. A deep learning model is developed to predict the six-month outcome from the preoperative photograph together with baseline clinical variables. Model performance is assessed by discrimination, calibration and prediction error, using the clinical measurement at six months as the reference standard. A secondary analysis examines whether the recession type assigned automatically from the photograph agrees with the type assigned by the examining periodontist. The model is developed and validated internally within this cohort; no external validation set is available. Its output is not shown to the operator and does not influence treatment. Reporting follows the TRIPOD recommendations for prediction model studies.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammed F Dogan, Resident
- Número de teléfono: +905433890065
- Correo electrónico: mfurkandogaan@gmail.com
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34854
- Reclutamiento
- Marmara University Faculty of Dentistry Department of Periodontology
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Contacto:
- Muhammed F Dogan, Resident
- Número de teléfono: +905433890065
- Correo electrónico: mfurkandogaan@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Systemically healthy patients (ASA I or II status) with no contraindications for periodontal surgery.
- Adult patients aged 18 to 65 years.
- Presence of isolated or multiple gingival recessions classified as Cairo RT1, RT2 or RT3 in the maxilla or mandible.
- Patients with good oral hygiene standards, defined as a Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) of < 20% at baseline.
- Presence of an identifiable Cemento-Enamel Junction (CEJ) (Crucial for AI segmentation).
Exclusion Criteria:
- Patients with uncontrolled diabetes, immune system disorders, or pregnant/lactating women.
- Teeth with cervical restorations or abrasions that obscure the CEJ.
- Malpositioned or rotated teeth that would distort the photographic angle for AI analysis.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Root coverage surgery cohort
Systemically healthy adults aged 18 to 65 years with Cairo RT1,RT2 pr RT3 gingival recessions, treated with a coronally advanced flap combined with a subepithelial connective tissue graft by a single operator and followed for six months.
All participants received the same surgical technique; no comparison group was formed and no participant was assigned to a treatment for the purposes of this study.
Standardised intraoral photographs and clinical measurements were obtained before surgery and at three and six months.
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A coronally advanced flap is raised over the recession defect and a subepithelial connective tissue graft harvested from the palate is positioned beneath it, after which the flap is sutured coronal to the cemento-enamel junction.
Graft thickness, length and width are recorded for each treated site.
The procedure was performed as routine clinical care and was not assigned for research purposes.
Preoperative intraoral photographs and baseline clinical variables are analysed by a deep learning model that predicts the outcome of root coverage surgery.
The model output is not used in clinical decision making and does not influence treatment; it is compared retrospectively with the outcome measured by the treating periodontist at six months.
The same photographs are also used to assign the recession type automatically, which is compared with the clinical assignment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accuracy of the model in predicting root coverage at six months
Periodo de tiempo: 6 months
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Difference between the root coverage predicted by a model based on preoperative intraoral photographs and baseline clinical characteristics, and the root coverage observed at six months.
Root coverage is expressed as the percentage of the baseline recession depth that is covered, calculated as [(baseline recession depth - six-month recession depth) / baseline recession depth] × 100, from probing measurements made by the treating periodontist from the cemento-enamel junction to the gingival margin.
Predictive accuracy is summarised as the mean absolute error in percentage points across all treated sites.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sensitivity and specificity of the model at the selected decision threshold
Periodo de tiempo: 6 months
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Proportion of sites correctly identified by the model among those that achieved the outcome (sensitivity) and among those that did not (specificity), evaluated at the operating point selected on the receiver operating characteristic curve.
Both proportions are reported with 95% confidence intervals.
The reference standard is the clinical measurement made at six months by the treating periodontist, using a periodontal probe from the cemento-enamel junction to the gingival margin.
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6 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Calibration of the model
Periodo de tiempo: 6 months
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Agreement between the probability predicted by the model and the frequency observed in the cohort, assessed by the calibration slope and intercept and displayed as a calibration plot.
Discrimination indicates whether the model ranks sites correctly; calibration indicates whether the predicted probabilities are numerically correct, and the two are reported separately because a model may rank well while producing miscalibrated probabilities.
The reference standard is the clinical measurement made at six months.
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6 months
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Agreement between the model-assigned and the clinician-assigned recession type
Periodo de tiempo: Baseline
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Proportion of treated sites at which the recession type assigned by the model from the preoperative photograph matches the type assigned by the examining periodontist, reported together with quadratic weighted kappa.
The reference standard is the clinical assignment recorded at baseline according to the criteria of Cairo et al.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Leyla Kuru, Professor, Marmara University Faculty of Dentistry Department of Periodontology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-09-02/2025-58
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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