Marmara University Faculty of Dentistry Department of Periodontology
Istanbul, 34854, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07775365
This study evaluates whether the outcome of root coverage surgery can be predicted from a preoperative intraoral photograph. Adults with Cairo RT1,RT2 or RT3 gingival recessions treated with a coronally advanced flap and a connective tissue graft are followed for six months. Standardised photographs and clinical measurements are obtained before surgery and at each follow-up visit. A deep learning model is developed to predict the surgical outcome from the preoperative photograph and baseline clinical variables, and its performance is compared with the outcome measured clinically at six months. The model does not influence treatment decisions.
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Request Info18 year–65 year
All sexes
Observational
Istanbul, 34854, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: Baseline
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.
Contact information is provided by the study sponsor or research team.
Marmara University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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