Outcome of Endodontic Retreatment in One or Two Visits

Официальное название

Clinical and Radiographic Outcome of Endodontic Retreatment in One or Two Visits: A Randomized Controlled Trial.

Обзор

This study is a prospective randomized controlled study of patients who come to the University and non-surgical root canal retreatment is considered as the election of choice in presence of periapical disease. The aim is to evaluate the success rate of non-surgical retreatment performed in one compared to two visit treatment up to 10 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of success, when performing root canal non-surgical retreatment in one or two visits.

Вмешательства

• Процедура Non-surgical root canal retreatment
  Non-surgical root canal retreatment

Первичные конечные точки

• Clinical post-operative pain [Срок оценки: Immediately post treatment]
• Clinical post-operative pain [Срок оценки: 4 hours post-treatment]
• Clinical post-operative pain [Срок оценки: 24 hours post treatment]
• Clinical post-operative pain [Срок оценки: 48 hours post treatment]
• Clinical signs or symptoms of periapical disease 1 [Срок оценки: 1 year]
• Clinical signs or symptoms of periapical disease 2 [Срок оценки: 2 years]
• Clinical signs or symptoms of periapical disease 4 [Срок оценки: 4 years]
• Clinical signs or symptoms of periapical disease 6 [Срок оценки: 6 years]
• Clinical signs or symptoms of periapical disease 10 [Срок оценки: 10 years]
• Radiographic periapical absence/presence of radiographic apical periodontitis [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1 [Срок оценки: 1 year]
• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2 [Срок оценки: 2 years]
• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4 [Срок оценки: 4 years]
• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6 [Срок оценки: 6 years]
• Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10 [Срок оценки: 10 years]

Критерии участия

Критерии включения

• Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
• Understands and is willing to comply with all study procedures and restrictions.
• Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
• Retreatment cases due to an endodontic failure.
• Diagnosis of apical periodontitis.
• Single or bi-radicular teeth.

Критерии исключения

• General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.
• Specific: root resorption, root fractures, impossibility of restoration and cases were secondary root canal treatment is not the treatment of choice.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universitat Internacional de Catalunya — Sant Cugat del Vallès

Идентификаторы

NCT: NCT04527705 · UICENDECL201501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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