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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in biochemically measured oxidative stress markers at 30th day in patients treated with epoxyamine/bioceramic root canal pastes.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The root canal paste to be used will be selected from identical black envelopes by another physician who will not participate in the treatment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Changes in biochemically measured oxidative stress markers at 30th day in patients treated with epoxyamine/bioceramic root canal pastes.
时间窗: three month aproximately
oxidative stress markers (myeloperoxidase, 8-epi, total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde) will be measured and compared biochemically in saliva samples taken from the patients on the first and thirtieth day.
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
时间窗: three month aproximately
results of oxidative stress measurement obtained from bioceramic group and epoxyamin group will be compared. comparsion will be performed with biochemical kits for saliva samples.
次要结局
- 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(three months aproximately)
研究者
bengi gülgü
Principle Investigator
T.C. ORDU ÜNİVERSİTESİ