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Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals

2026年8月23日 更新者:Nourhan Sayid Mohammed、Minia University

Influence of Irrigant Delivery Systems on the Incidence of Postoperative Discomfort in Oval Canals : A Randomized Clinical Trial

The main aim of endodontic therapy is to disinfect the entire root canal system (RCS), which requires the elimination of microorganisms and microbial components. This goal is pursued by chemo-mechanical debridement of the RCS.

Attaining this goal remains challenging due to the complex and variable anatomy of the root canal system, which includes intricate structures such as fins, isthmuses, lateral canals, and apical deltas that are often inaccessible to mechanical instrumentation.

To overcome these anatomical limitations, various irrigation protocols have been developed to enhance the penetration and effectiveness of irrigating solutions.The use of different activation techniques-such as manual dynamic agitation, irrigation needle, sonic and ultrasonic activation, and negative pressure irrigation systems-aims to improve the distribution, exchange, and cleaning ability of irrigants within hard-to-reach areas of the canal system.These approaches are designed to maximize microbial reduction and promote more effective removal of debris and smear layer remnants.

研究概览

地位

招聘中

条件

详细说明

Despite their proven efficacy in improving canal cleanliness and disinfection, these irrigation protocols are not without drawbacks. Mechanical and chemical interactions may lead to extrusion of irrigants or debris beyond the apical foramen, potentially causing irritation of the periapical tissues. As a result, patients may experience varying degrees of postoperative pain or discomfort following treatment, depending on the irrigation method and activation technique employed.

Manual Agitation:

Manual agitation is a simple and cost-effective method used to enhance irrigant penetration and exchange within the root canal system. It involves the use of instruments such as gutta-percha cones or endodontic brushes to manually move the irrigant inside the canal. Although this technique can improve irrigant distribution, its effectiveness is limited by the operator's ability and the lack of continuous flow or activation energy, making it less efficient in complex canal anatomies.

Conventional Needle Irrigation:

Conventional needle irrigation remains the most widely practiced method of delivering irrigants into the canal. Typically, side-vented or open-ended needles are used to dispense the solution within 1-2 mm of the working length. While this technique allows controlled delivery, its major limitation lies in the restricted penetration of irrigant into irregularities and apical areas due to vapor lock and inadequate fluid replacement. Consequently, canal cleanliness and disinfection depend heavily on the needle design, placement depth, and flow rate.

Sonic and Ultrasonic Activation:

Sonic and ultrasonic activation techniques utilize energy transmitted through oscillating tips or files to enhance the dynamic movement of irrigants within the canal. Sonic devices operate at lower frequencies (1-10 kHz), generating acoustic streaming that improves debris removal. Ultrasonic systems function at higher frequencies (25-40 kHz), producing vigorous cavitation and acoustic streaming effects that significantly enhance the cleaning and disinfecting potential of irrigants. However, excessive activation or improper use may increase the risk of irrigant extrusion and subsequent postoperative discomfort.

Negative Pressure Irrigation:

Negative pressure systems, such as the EndoVac or SafeClean, were developed to minimize the risk of apical extrusion and improve irrigant exchange in the apical third.These systems deliver irrigant from the coronal portion while simultaneously applying negative pressure to draw the solution down the canal and aspirate it at the apex. This design enables effective irrigation of the apical region while maintaining safety and preventing periapical irritation.There is limited clinical evidence comparing the effect of different irrigation/activation protocols on postoperative pain in canines and premolars .

研究类型

介入性

注册 (估计的)

32

阶段

  • 不适用

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。

学习联系方式

研究联系人备份

学习地点

      • Minya、埃及
        • 招聘中
        • Endodontics Department Faculty of Dentistry
        • 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:

  • Inclusion Criteria Patients aged between 18 and 45 years.
  • Patients requiring primary root canal treatment.
  • Patients in good general health..
  • Subjects classified as ASA-1 following the classification proposed by the American Society of Anesthesiologists.

Exclusion Criteria:

  • Patients with systemic diseases affecting pain perception or healing.
  • Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
  • Pregnant or lactating women.
  • Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease. .

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group of Sodium hypochlorite
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% as irrigating solution used as 20 mL irrigant per canal & EDDY sonic activation tips (Device)
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
其他名称:
  • Sonic activation, and negative pressure systems
有源比较器:Group of Safe Clean system (Device)
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% & Apical Negative Pressure Irrigation using Safe Clean system
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
其他名称:
  • Sonic activation, and negative pressure systems
有源比较器:Group of Sodium hypochlorite & manual agitation technique
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% & manual agitation technique with apical master gutta percha cone (Device)
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
其他名称:
  • Sonic activation, and negative pressure systems
有源比较器:Group of Sodium Hypochlorite & Side vented needle (Device)
About 8 cases will have Endodontic treatment of single-rooted teeth irrigated with Sodium hypochlorite (NaOCl) 5.25% & side vented needle (Device)
to compare the effect of all different irrigation and activation protocols manual agitation, conventional needle irrigation, sonic activation, and negative pressure systems (such as Safe Clean) on the incidence and intensity of postoperative pain following endodontic treatment of canines and premolars
其他名称:
  • Sonic activation, and negative pressure systems

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
Post-operative pain
大体时间:7 Days
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48,and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups
7 Days

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。

调查人员

  • 学习椅:Dalia Ali Ahmed Moukarab, M.D、Professor and Head of the Endodontics Department, Faculty of Dentistry

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 (实际的)

2026年4月14日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月14日

研究注册日期

首次提交

2026年8月16日

首先提交符合 QC 标准的

2026年8月23日

首次发布 (实际的)

2026年8月26日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月23日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • Discomfort in oval canals

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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