- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Muhammed F Dogan, Resident
- Telefoonnummer: +905433890065
- E-mail: mfurkandogaan@gmail.com
Studie Locaties
-
-
Istanbul
-
Istanbul, Istanbul, Turkije (Türkiye), 34854
- Werving
- Marmara University Faculty of Dentistry Department of Periodontology
-
Contact:
- Muhammed F Dogan, Resident
- Telefoonnummer: +905433890065
- E-mail: mfurkandogaan@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Accuracy of the model in predicting root coverage at six months
Tijdsspanne: 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.
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sensitivity and specificity of the model at the selected decision threshold
Tijdsspanne: 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.
|
6 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Calibration of the model
Tijdsspanne: 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.
|
6 months
|
|
Agreement between the model-assigned and the clinician-assigned recession type
Tijdsspanne: 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.
|
Baseline
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Leyla Kuru, Professor, Marmara University Faculty of Dentistry Department of Periodontology
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025-09-02/2025-58
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .