Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer

Официальное название

The Outcome of Endodontic Treatment and Retreatment With a Bioceramic Sealer: A Prospective Randomized Controlled Clinical Study

Обзор

This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of treatment and retreatment of canals using BioRoot ™ RCS cement compared with AH Plus up to 6 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment of root canals filled with BioRoot ™ RCS compared to gutta-percha and AH Plus sealer.

Вмешательства

• Другое BioRoot RCS® root canal sealer
  Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
• Другое AH Plus® root canal sealer
  Root canal obturation with guttapercha and AH Plus® root canal sealer

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 [Срок оценки: 1 year]
• Clinical signs or symptoms of periapical disease [Срок оценки: 2 years]
• Clinical signs or symptoms of periapical disease [Срок оценки: 4 years]
• Clinical signs or symptoms of periapical disease [Срок оценки: 6 years]
• Radiographic periapical healing [Срок оценки: 1 year]
• Radiographic periapical healing [Срок оценки: 2 years]

Вторичные конечные точки (8)

• Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Срок оценки: 1 year]
• Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Срок оценки: 2 years]
• Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Срок оценки: 4 years]
• Correlation of prognostic factors and clinical signs or symptoms of periapical disease [Срок оценки: 6 years]
• Correlation of prognostic factors and radiographic periapical healing [Срок оценки: 1 year]
• Correlation of prognostic factors and radiographic periapical healing [Срок оценки: 2 years]
• Correlation of prognostic factors and radiographic periapical healing [Срок оценки: 4 years]
• Correlation of prognostic factors and radiographic periapical healing [Срок оценки: 6 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.
• Diagnosis of irreversible pulpitis or apical symptomatic / asymptomatic periodontitis.
• Retreatment cases due to an endodontic failure.
• 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 primary or 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: Да

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: NCT04528979 · UICENDECL201703

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗