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Influence of Sealer Composition on Post-Endodontic Pain

2026年8月11日 更新者:Nourhan Rabie Ahmed、Minia University

Influence of Sealer Composition on Post-Endodontic Pain: A Prospective Comparative Analysis of Three Root Canal Sealers

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life.

The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week.

研究概览

地位

招聘中

详细说明

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life .

The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week . The pathophysiology of postoperative pain involves mechanical, chemical, or microbial injury to the periapical tissues, which triggers an acute inflammatory response characterized by the release of inflammatory mediators, vasodilation, increased vascular permeability, and leukocyte migration, ultimately activating sensory neurons and generating pain.

The etiology of PP is multifactorial, including patient-related factors such as age, gender, tooth type particularly mandibular molars preoperative pain, and periapical radiolucency, as well as treatment-related factors such as instrumentation protocol, irrigation solution, working length determination, occlusal adjustment, number of visits, anesthesia type, and prophylactic analgesics. Understanding these variables allows clinicians to select techniques and materials that minimize postoperative discomfort.

Root canal obturation plays a critical role in postoperative pain, as sealers may come into direct contact with periradicular tissues or extrude through the apical foramen, eliciting cytotoxic and inflammatory responses . The chemical composition and biocompatibility of the sealer influence tissue reaction, periapical healing, and subsequent pain perception.

Traditionally, epoxy resin-based sealers, such as AH Plus®, have been considered the gold standard due to their excellent sealing properties, radiopacity, dimensional stability, and clinical performance; however, extrusion of these sealers has been associated with cytotoxicity and inflammation.

Calcium hydroxide-based sealers have long been used in endodontics, providing antibacterial effects, low cytotoxicity, and osteogenic and cementogenic potential, contributing to periapical repair.

More recently, calcium silicate-based bioceramic sealers, including tricalcium silicate formulations like BioRoot and EndoSeal MTA, have gained popularity due to their bioactivity, biocompatibility, ability to set in humid conditions, alkaline pH, calcium ion release, antimicrobial properties, and promotion of tissue regeneration with lower inflammatory mediator production.

These properties suggest that bioceramic sealers may reduce postoperative pain compared to traditional sealers, while supporting enhanced periapical healing and osteogenic induction.

Despite studies evaluating postoperative pain with different sealers, results remain controversial, and there is limited evidence specifically comparing the effects of epoxy resin-based versus calcium silicate-based sealers on pain outcomes following single-visit endodontic treatment.

This highlights a need for further randomized clinical trials to assess the incidence and severity of postoperative pain associated with these materials, particularly in patients with varying pulpal and periapical conditions.

研究类型

介入性

注册 (估计的)

66

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:

  • Patients requiring primary root canal treatment.
  • Patients with acute irreversible pulpitis.
  • Patients in good general health

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 A (Calcium Hydroxide-based Sealer: Sealapex):

About 22 cases will be subjected to:

  1. Canals will be dried using sterile paper points, avoiding excessive desiccation to maintain optimal canal conditions prior to sealer placement.
  2. The sealer will be dispensed according to the manufacturer's instructions. Gutta-percha master cones will be lightly coated with the sealer and inserted to the full working length. Additional sealer may be applied into the canal using a lentulo spiral or an appropriate intracanal delivery tip when indicated.
  3. Accessory gutta-percha cones will be inserted into each canal to fill the spaces created by the spreader using a lateral compaction technique.
  4. After achieving optimal obturation of the canal, excess gutta-percha will be seared off at the canal orifices using a heated instrument.
  5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet moistened with saline.
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
其他名称:
  • Bioceramic Sealer and Resin-based Sealer
有源比较器:Group B (Bioceramic Sealer: Well-Root):

About 22 cases will be subjected to:

  1. Canals will be dried using sterile paper points, avoiding over drying to maintain slight moisture within the dentinal tubules, which is favorable for the setting reaction of the bioceramic sealer.
  2. The premixed bioceramic sealer will be dispensed directly into the canal using the manufacturer's intracanal delivery tip adjusted to 1-2 mm short of the working length, or applied onto the master gutta-percha cone prior to insertion.
  3. The master gutta-percha cone will be inserted to the full working length. Accessory cones will be placed when necessary using a lateral compaction technique to ensure complete canal obturation.
  4. After achieving optimal filling, excess gutta-percha will be seared off at the canal orifices using a heat carrier.
  5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet lightly moistened with saline.
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
其他名称:
  • Bioceramic Sealer and Resin-based Sealer
有源比较器:Group C (Resin-based Sealer: ADSEAL):

About 22 cases will be subjected to:

  1. Canals will be dried thoroughly using sterile paper points to ensure a moisture-free environment suitable for resin-based sealer application.
  2. The resin-based sealer will be mixed according to the manufacturer's instructions and applied into the canal using a lentulo spiral or coated onto the master gutta-percha cone before insertion to the working length.
  3. Accessory gutta-percha cones will be inserted using a lateral compaction technique to achieve dense canal obturation.
  4. Excess gutta-percha will be removed at the canal orifices using a heated instrument after completion of obturation.
  5. The pulp chamber will be cleaned from excess sealer using a sterile cotton pellet moistened with alcohol or saline as recommended by the manufacturer.
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
其他名称:
  • Bioceramic Sealer and Resin-based Sealer

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 Endodontic Pain Intensity
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, Professor、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11日

首先提交符合 QC 标准的

2026年8月11日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月11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

  • Post-Endodontic Pain

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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