Effect of Different Root Canal Sealers on Oxidative Stress Markers

Официальное название

Evaluation of Oxidative Stress in Patients With Chronic Apical Periodontitis Treated With Single Session Root Canal Treatment Using Different Root Canal Sealers: in Vivo Study

Обзор

The goal of this clinical trial is to primary purpose investigate and compare oxidative stress markers in patients with chronic apical periodontitis treated with different root canal paste in a single session. The main questions it aims to answer are: Is there a change in oxidative stress markers measured from saliva after root canal treatment? Is there a difference between the change of oxidative stress markers in patients using different root canal sealers after root canal treatment? Researchers will compare bioceramic-based and epoxy resin-based root canal sealers to see if there are significant differences in oxidative stress markers measured from patients' saliva after root canal treatment. * Participants will be informed about all procedures before starting the clinical process. * Participants are expected to allow saliva sampling two times: first sample will be collected on root canal treatment session and second sample will be collected on the 30th day after root canal treatment. * Participants will be informed in writing about the treatment procedure before starting the clinical process. * Participants are expected to sign the informed consent form on a voluntary basis.

Вмешательства

• Другое Root Canal Treatment and Sample Collection
  Single session root canal treatment procedure will be performed with VDW Gold Reciproc device and reciprocal files (Endo T-Must, Dentac, Turkey). Endodontium Samples will be collected from each patient's root canal, with 15 Hedström files (Dentsplay).
• Диагностический тест PAI Score Comparasion
  PAI scores of the patients will be determined with periapical films taken before treatment and compared with oxidative stress markers before and after treatment for the epoxyamine group and bioceramic group.

Первичные конечные точки

• Changes in biochemically measured oxidative stress markers at 30th day in patients treated with epoxyamine/bioceramic root canal pastes. [Срок оценки: three month aproximately]
• Comparison of the changes observed in biochemically measured oxidative stress markers of patients in the bioceramic group and patients in the epoxyamine group at day 1 and day 30 [Срок оценки: three month aproximately]

Вторичные конечные точки (1)

• Investigation of the relationship between biochemically measured oxidative stress markers from endodontium and initial saliva samples obtained from all patients and PAI score determined by periapical films [Срок оценки: three months aproximately]

Критерии участия

Критерии включения

• Systemically healthy, ASA1 patients,
• Phase 1 periodontal treatment was performed,
• Diagnosed with chronic apical periodontitis in a single tooth with 2 or more roots in the mouth,
• The lesion measured <2 cm on radiographic evaluation,
• The vitality of the tooth was checked by EPT (Ai-Pex, Woodpecker, China) and Cold test (Cerkamed, Poland) and confirmed to be devitalised,
• Socioculturally able to participate in the treatment,
• Individuals who did not smoke or drink alcohol

Критерии исключения

• Patients who have used antibiotics in the last three months and analgesics in the last two weeks
• Patients who smoke and/or abuse alcohol
• Patients younger than 18 years or older than 45 years,
• Patients with controlled or uncontrolled systemic disease and life-threatening conditions (ASA 2,3,4,5,6)
• Pregnant or lactating women,
• Patients with poor oral hygiene,
• Patients who had head and neck radiotherapy,
• With obesity,
• Active periodontal disease,
• Periodontal pocket depth over 3mm,
• There is enough loss of material in the relevant tooth to prevent adequate isolation or to require post placement,
• Clinical examination of the relevant tooth showing symptoms in percussion-palpation,
• Radiographically, the lesion is seen in relation to anatomical formations such as the mandibular canal and maxillary sinus,
• Patients who required prophylactic antibiotic use before invasive dental procedures were excluded from the study.
• Patients who did not attend the follow-up appointment and patients who experienced complications during expansion (instrument seperation, perforation, etc.) were excluded from the study.

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

Turkey (Türkiye) · 1 центр

• Ordu University — Ordu

Идентификаторы

NCT: NCT07059481 · 2024/53

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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