The Role of the Pre-operative Condition and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars

Официальное название

The Role of Wolters Pulpitis Classification, Apical Periodontitis, and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars: A Randomized Controlled Trial

Обзор

This study aims to evaluate the effect of prognostic factors, such as the severity of pulpal inflammation, carious pulp exposure, and the presence of apical periodontitis, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis. It also aims to investigate the role of artificial intelligence-assisted diagnosis in predicting the prognosis of full pulpotomy.

Подробное описание

* Patients with mature, permanent molars diagnosed with irreversible pulpitis will be enrolled in the study. * The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification. * Pre-operative digital radiographs will be taken, and radiographic caries depth will be assessed. * The presence of pre-operative apical periodontitis will be recorded. * An artificial intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure and apical periodontitis. * The patients will be randomly allocated to receive either full pulpotomy or conventional root canal treatment. * The cases will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. The accuracy of the AI software will be compared to the clinical findings of pulpal exposure after caries removal.

Вмешательства

• Процедура Conventional root canal treatment
  The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
• Процедура Full pulpotomy
  The patients will receive full pulpotomy as follows: -Under rubber dam isolation, the operator will perform caries removal, complete the access cavity preparation, achieve hemostasis in all canals, and apply the bioceramic material. The operator will seal the cavity with a glass ionomer restoration.

Первичные конечные точки

• Percentage of Successful Cases [Срок оценки: After 1, 3, and 6 months.]
• Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure [Срок оценки: On the day of the procedure]

Критерии участия

Критерии включения

• Mature permanent molars with irreversible pulpitis.
• Presence of bleeding from all canals.
• The tooth is not periodontally compromised.

Критерии исключения

• Non-vital teeth.
• Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
• Molars with immature roots.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 2 центра

• Misr International University (MIU) — Cairo
• Misr International University — Cairo

Идентификаторы

NCT: NCT07340606 · MIU-IRB-2425-036

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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