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Impact of Minimally Invasive Endodontic Treatment on the Prognosis of Mandibular Permanent Molars With Necrotic Pulp and Apical Periodontitis

2026年8月8日 更新者:Mohamed Ashraf Abdeen
Statement of the problem: The effectiveness of minimally invasive endodontic treatments in managing necrotic pulp with apical periodontitis remains understudied. Aim of the study: This research aims to evaluate the outcomes of minimally invasive versus traditional root canal treatments in patients with necrotic pulp associated with apical periodontitis. Material and methods: sixty healthy patients of both genders aged from 20 to 50 years old suffering from necrotic pulp associated with apical periodontitis in their lower first molars with four root canals will be included in this study. The initial assessment will include a preoperative CBCT scan. Participants will be randomly assigned according to the type of endodontic treatment to two groups; a traditional treatment group (Trad); in which a traditional access cavity design and root canal preparation extending three sizes beyond the initial apical file using taper .04 rotary files will be accomplished and a minimally invasive group (MI) in which a conservative access cavity and a conservative root canal preparation up to #20/.04 will be performed. Both groups will receive an identical irrigation protocol during root canal instrumentation augmented with passive ultrasonic activation. Immediately following biomechanical preparation, the root canals will be filled with single cone obturation technique. Root canal disinfection will be evaluated using a culture method in which two bacterial samplings will be collected, one before and another after the biomechanical preparation. Patients will be monitored over 12 months, concluding with a follow-up CBCT scan to assess periapical healing. Data will be collected and statistically analyzed.

研究概览

地位

尚未招聘

研究类型

介入性

注册 (估计的)

60

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Asyut Governorate
      • Asyut、Asyut Governorate、埃及
        • Faculty of dentistry, Assiut university
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Participants with free medical history (category: American Society of Anaesthesiologists class I) from either gender aged from 20 to 50 years old.
  2. Necrotic lower first molars with four root canals (two mesials and two distals).
  3. Teeth have a periapical radiolucency with a diameter of 2-4 mm in CBCT images.
  4. Teeth show root curvature of 10°-20° as described by Schnider.
  5. Participant that indicated for single visit root canal treatment.

Exclusion Criteria:

  1. Calcified or non-negotiatable teeth.
  2. Participants who cannot apply for the follow-up schedule.
  3. Teeth that show any signs of cracks or vertical root fractures.
  4. Teeth that show less than 50% of sound coronal tooth structure.
  5. Periodontally affected teeth.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Traditional group
In this group traditional access cavity and canal preparations is done
Root canal treatment is done
有源比较器:Minimally invasive group
In this group conservative access cavity and minimally invasive root canal preparation is done
Root canal treatment is done

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Success rate
大体时间:1 year follow up

A case is deemed successful if there is no clinical signs and symptoms of infection or inflammation and radiographic bone healing.

The success rate for each group will be determined by the ratio of successful cases to the total number of cases in that group.

1 year follow up

次要结果测量

结果测量
措施说明
大体时间
Healing of periapical lesion
大体时间:1 year
The change in the size of periapical radiolucencies will be assessed through a comparison of CBCT images taken preoperatively and at the 12-month follow-up. This evaluation will be conducted by two independent operators who are not aware of the treatment group assignments to ensure unbiased results.
1 year
Bacterial load
大体时间:Within 2 days after intervention

The bacterial levels within the root canals will be quantified at two critical stages of the treatment process:

S1: Immediately following the creation of the access cavity, prior to initiating any cleaning or shaping procedures. This step is crucial for determining the initial bacterial load present in the root canal system.

S2: Following irrigant activation. This measurement will provide insight into the efficacy of the cleaning and shaping procedures, as well as the irrigation protocol, in reducing the bacterial population within the canal. These bacterial samples will be collected using sterile a three size #15 paper points which will be inserted into the canals to absorb the canal contents. This method ensures a standardized approach to bacterial sampling at these specified stages of the treatment.

Within 2 days after intervention
Treatment duration
大体时间:During procedure
The total time taken to complete the treatment procedure, from the beginning of the access cavity preparation to the completion of obturation, will be meticulously recorded for each case.
During procedure
Iatrogenic errors
大体时间:During procedure
Any occurrences of iatrogenic errors, such as instrument separation, will be noted and recorded. This data will provide insight into the potential risks associated with each treatment approach.
During procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月23日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年7月22日

首先提交符合 QC 标准的

2026年8月8日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Minimally invasive endo

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

All collected IPD

IPD 共享时间框架

Beginning after publication of results and ending after 2 years

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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