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Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases (RCT)

2026年6月10日 更新者:Ain Shams University

Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases: A Randomized Controlled Clinical Trial

The aim of this clinical trial is to evaluate anti-inflammatory effect of various intracanal medications:

  1. Calcium Hydroxide Slurry mixed with 3% Sodium Hypochlorite
  2. Calcium Silicate
  3. Calcium Hydroxide

In retreatment cases in terms of:

  1. Biological Evaluation: Biomarker (IL 1B)
  2. Radiographic Evaluation: CBCT
  3. Clinical Evaluation: Pain Score (VAS)

研究概览

详细说明

Sixty patients presenting with failed root canal treated lower first molars with periapical lesion were included in this randomized controlled single-center clinical superiority trial with two parallel arms and randomly allocated to 3 equal groups (n = 20) according to the type of ICM used. Patients were randomly allocated to receive either Ca(OH)2 slurry that was prepared from pure Ca(OH)2 powder mixed with 3% NaOCl, calcium-silicate (Bio-C Temp) or calcium hydroxide (CH) as ICM. Teeth were instrumented using a rotary file system (M3 pro Gold) and irrigated with 3% NaOCl. Subsequently, the root canals were dressed with a Ca(OH)2 + NaOCl or calcium silicate (test groups) or Ca(OH)2 (control group). Periapical fluid samples were collected after accessing the root canal in the first visit and after the root canal dressing removal in the second visit 2 weeks later using paper point. Samples were transferred to the microbiology lab immediately and levels of pro-inflammatory marker (IL1B) were measured using a specific enzyme-linked immunosorbent assay (ELISA) immediately after the second visit to test the reduction in inflammatory marker level after intracanal medication usage. Also, preoperative and 12 months-postoperative radiographic evaluation by CBCT were obtained to measure volumetric reduction in lesion size using segmentation technique. And patients rated their pain pre-operatively and then after 6, 12, 24, 48, 72 h and 7 days using the VAS score. Clinical and radiographic follow-up evaluations were scheduled for 1 week, 1 month, 6 months and 12 months by examining the patient clinically using palpation and percussion tests and pain questionnaire and periapical digital radiographs to compare reduction in lesion size.

研究类型

介入性

注册 (估计的)

60

阶段

  • 阶段1

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

学习地点

      • Cairo、埃及
        • 招聘中
        • Ain Shams University
        • 接触:
          • Ain Shams University
          • 电话号码:00201000397491

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

是的

描述

Inclusion Criteria:

  1. Age: 21-45 years.
  2. Medically free patients. (ASA Class 1)
  3. Gender: males and females
  4. Patients who are cooperative at operation and in attendance at scheduled follow-up visits.
  5. Restorable root canal treated permanent lower first molars with periapical lesions.
  6. Small (<5 mm) or medium periapical lesion size (5-10 mm)

Exclusion Criteria:

  1. Patients with a history of allergic reactions to any of the study materials.
  2. Teeth that become non-restorable after complete caries excavation.
  3. Teeth that have mobility or deep periodontal pockets.
  4. Teeth with internal or external resorption.

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
实验性的:Calcium Silicate Intracanal Medication
Calcium silicate-based bioceramic Intracanal Medication as Bio C-Temp (Angelus)
Calcium silicate-based bioceramic materials have gained attention for their bioactivity and biocompatibility, acting through hydration with calcium hydroxide release followed by hydroxyapatite formation that promotes healing. Bio-C Temp is an example, characterized by high calcium ion release, alkaline pH, adequate radiopacity, and good biocompatibility.
实验性的:Calcium Hydroxide Slurry mixed with Sodium Hypochlorite
Calcium Hydroxide slurry mixed with 3% Sodium Hypochlorite
Combining calcium hydroxide with sodium hypochlorite (NaOCl) has been proposed. NaOCl provides rapid and potent antimicrobial and tissue-dissolving effects, while Ca(OH)₂ offers prolonged action. Both agents retain their properties when combined, and this combination may produce a synergistic effect that enhances disinfection and reduces chair time in two-visit treatment protocols.
有源比较器:Calcium Hydroxide
Calcium Hydroxide Intracanal Medication (Control Group)
Calcium hydroxide ICM being the most widely used due to its high alkalinity, antimicrobial properties, endotoxin neutralization, and ability to reduce periapical inflammation. It is applied as an aqueous mixture or polyethylene glycol-based paste and provides a slow but sustained antimicrobial effect. Despite their benefits, Ca(OH)₂ medicaments re limited by their solubility, susceptibility to tissue fluids, potential to weaken tooth structure over time, and reduced effectiveness against resistant microorganisms such as Candida Albicans and Enterococcus Faecalis.

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
Biological Evaluation of inflammatory marker (IL-1B)
大体时间:1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.
IL-1B collected by periapical fluid sample using paper points and measured using ELISA.
1st sample is collected in the first visit after root canal filling removal while 2nd sample is collected after intracanal medication removal in the second visit. Both visits are 14 days apart.

次要结果测量

结果测量
措施说明
大体时间
Radiographic Evaluation using limited FOV CBCT
大体时间:1 year between pre- and post-operative CBCT scans.
Pre-operative and post-operative limited FOV CBCT scans are taken to compare volumetric reduction in periapical lesion size.
1 year between pre- and post-operative CBCT scans.

其他结果措施

结果测量
措施说明
大体时间
Clinical Evaluation using Pain Score (Visual Analogue Scale)
大体时间:Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals
evaluation of pain score using Visual Analogue Scale on a scale of 0-10 with 0 representing no pain and 10 representing the most severe pain (subjective)
Pre-operative and Post-operative at 6, 24, 48, 72 hours and 1 week intervals

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 (实际的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年6月7日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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

在美国制造并从美国出口的产品

不

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