The Effect of Apical Enlargement on Microbial Load Before and After Passive Ultrasonic Activation in Asymptomatic Teeth Periapical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- apical shaping size
研究概览
简要总结
The goal of this observational study is to define the role of apical shaping and irrigation activation on root canal cleanliness. The main questions it aims to answer are:
- does the effectiveness of irrigation activation depends on apical shaping?
- can a similar success be achieved by increasing apical shaping without irrigation activation Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].
详细描述
The aim of this study is to evaluate the effect of apical enlargement with two different diameters on the intraradicular microbiota of teeth with chronic apical periodontitis lesion before and after passive ultrasonic irrigation activation using ddPCR analysis in vivo.The study was planned as a randomized controlled clinical trial. We are planning to include 24 patients who was referred to the Istanbul Medipol University Faculty of Dentistry Endodontic Clinic with the need for root canal treatment, with asymptomatic chronic apical periodontitis. 24 patients will randomly be assigned to two groups according to the apical shaping size during root canal treatment: 25/.04 and 35/.04. Microbiological sampling of the teeth will be done with paper cones in three steps during the root canal treatment: 1. Sterility control samples (SR1) from the tooth surface after cavity preparation, 2. The first microbiological sample (S1) from the root canal after the initial file reaches the working length. 3. The second microbiological sample (S2) from the root canal after the shaping and irrigation of the root canal is finished. 4. The third microbiological sample (S3) from the root canal after the irrigation activation in the root canal is finished.The samples will be sent to the genetic analysis laboratory for further analysis in the cold chain using a Droplet Digital PCR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 18-65
- •Patients complying with the ASA1 and ASA2 classification (American Society of Anesthesiology)
- •Patients who has molar teeth with radiolucent lesions in the periapical region
- •The volunteer himself/herself or his/her legal representative wants to participate in the research by signing the 'Voluntary Consent Form'.
- •Being able to tolerate the treatment physically and mentally
排除标准
- •Patients who have taken antibiotics/corticosteroids in the last 3 months
- •Patients with systemic disease
- •Teeth that cannot be properly isolated with a rubber dam
- •Teeth without coronal sealing,
- •Teeth with periodontal pocket depth>4 mm and teeth with crown / root fracture.
- •Individuals who continue or are considering starting orthodontic treatment during the research
- •Pregnant and lactating individuals
- •The volunteer himself/herself or his/her legal representative does not want to participate in the research by signing the 'Voluntary Consent Form'.
- •Teeth that are damaged enough to require post-core treatment.
结局指标
主要结局
apical shaping size
时间窗: through study completion, an average of 1 year
does apical shaping size affect the microbial load in the root canal after shaping and irrigation finishes? microbial load after two different apical shaping size will be compared between two groups. Droplet Digital PCR will be used to measure and compare the microbial load within the root canal before and after irrigation protocol in each group to measure this outcome.
irrigation activation
时间窗: through study completion, an average of 1 year
does irrigation activation affect the microbial load in the root canal? microbial load after chemomechanical cleaning of the root canal and after the irrigation activation will be compared. Droplet Digital PCR will be used to measure microbial load before after irrigation activation in each canal to see its effect on reduction fo microbial load within the root canal.
次要结局
- the effect of apical shaping in irrigation activation(through study completion, an average of 1 year)
研究者
Tan Firat Eyuboglu
Associate Professor
Istanbul Medipol University Hospital