Evaluation of the Effect of Conservative Root Canal Instrumentation on the Release of Inflammatory Mediators in Root Canal Treatments: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Release of inflammatory mediators
研究概览
简要总结
The goal of this clinical trial is to evaluate the expression of inflammatory mediators in the crevicular fluid and periodontal ligament after one-visit root canal treatment of mandibular molars of patients with asymptomatic irreversible pulpitis using 3 different file systems.
The main question it aims to answer is: Does conservative root canal preparation cause decreased expression of inflammatory mediators compared to conventional root canal preparation?
In this context, patients will be divided into 3 groups based on the file systems as follows: ProTaper Gold, OneShape, and TruNatomy up to apical size #25. Both inflammatory mediator expression and postoperative VAS values will be compared.
详细描述
The below-mentioned steps will be performed in the scope of this study:
- Ethical approval has been obtained.
- The sample size calculation was performed (90% power, 0.597 effect size, 20 patients per group)
- Patients aged 18-60 with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination and without any systemic disease will be included.
- Only mandibular first and second molar teeth that do not have complex anatomy, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks will be included.
- Patients with acute symptoms, a history of taking analgesics 48 hours or antibiotics within 1 month prior to the visit, being pregnant and lactating, and having several periodontal problems will be excluded.
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Immature apexes and trauma cases will also be excluded. 6) Selected patients will be informed about the study, and written consent will be obtained from all patients.
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Patients will be randomly distributed into groups using a software (www.randomizer.org). Moreover, patients will be blinded regarding the file system they use.
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A single operator will perform all endodontic treatments in the same clinical conditions.
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
Patients who will be treated and the assessor who will perform the analysis in lab will be blinded regarding which file is used for each patient.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-60
- •Patients with asymptomatic irreversible pulpitis that has been confirmed by intraoral and extraoral examination
- •Patients with pain pain between 0 and 3 on the VAS scale
- •Patients without any systemic disease
- •Mandibular first and second molar teeth without complex root canal anatomy, calcifications, periapical lesions, deep periodontal pockets (PAI<2), and any fractures or cracks
排除标准
- •Patients with acute symptoms
- •Patients who have a history of taking analgesics 48 h or antibiotics within 1 month prior to the visit
- •Patients who are being pregnant and lactating
- •Patients with several periodontal problems
- •Patients with systemic disease
- •Teeth with immature root apexes
- •Trauma cases
结局指标
主要结局
Release of inflammatory mediators
时间窗: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin IL-6
Measurement of Substance P
时间窗: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Substance P
Measurement of IL-10
时间窗: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of IL-10
Measurement of Prostaglandin E2
时间窗: Before root canal treatment (Day 0), at 24 hours, and at 72 hours
Measurement of Prostaglandin E2
次要结局
- Postoperative pain assessment using visual analog scale(Before root canal treatment (Day 0), at 24 hours, and at 72 hours)
研究者
Sıla Nur Usta
Assistant Professor
Saglik Bilimleri Universitesi