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临床试验/NCT07388888
NCT07388888尚未招募4 期

Comparative Evaluation of Anti-Bacterial Efficacy Of Two Different Intracanal-Medicaments and Their Effect On Post-Operative Pain Level (A Randomized Clinical Trial)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Bacterial load.

研究概览

简要总结

Evaluation of antibacterial effect of two different intracanal medicaments on bacterial load in infected mature permanent teeth and their effect on post-operative pain level.

详细描述

Microorganisms within the root canal system exist as complex, multispecies biofilms made up of microcolonies that adhere permanently to each other and to surfaces such as dentin. The characteristics of these biofilms-including their composition, thickness, and location-vary according to environmental conditions like nutrient availability, pH, oxygen levels, and exposure to the oral cavity. Endodontic treatment aims to save teeth with damaged pulp tissue, as maintaining natural teeth is essential for proper oral function and overall health. Understanding the specific microorganisms involved in endodontic infections is crucial for explaining disease progression and selecting the most effective treatment strategies.

Because of the intricate anatomy of the root canal system, both mechanical instrumentation and chemical irrigation are required to reduce microbial load. However, chemo-mechanical debridement alone is often insufficient, allowing some bacteria to persist within the canal. As a result, antimicrobial intracanal medicaments have been introduced to enhance disinfection. Although several medicaments are currently used, many show limitations such as microbial resistance or an inability to simultaneously control intracanal infection and periapical inflammation. Additionally, antimicrobial agents may interact with the immune system, potentially suppressing or stimulating immune responses.

Enterococci, particularly *Enterococcus faecalis*, are frequently associated with persistent endodontic infections due to their resistance to treatment and ability to survive harsh conditions. Calcium hydroxide, a material introduced to dentistry in the early 20th century, is widely used as an intracanal medicament but has limited effectiveness against certain bacteria such as *E. faecalis*. Recent interest has focused on nanoparticles, which range from 1 to 100 nm in size and possess unique antimicrobial properties with reduced resistance. Among these, chitosan nanoparticles-derived from chitin found in crustacean exoskeletons-have gained attention for their biocompatibility and antibacterial effects. Effective intracanal medicaments are also important in reducing postoperative pain, which is commonly linked to bacterial irritation following endodontic treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • free medical history,
  • mature infected permanent single rooted teeth diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization and restoration.

排除标准

  • Patients who are not included in the age range of the study or having a systemic condition.
  • Teeth with severe fractures or resorption or periodontally compromised.

研究组 & 干预措施

calcium hydroxide (Ca(OH)2)

Active Comparator

intracanal medicament in infected root canal

干预措施: Calcium Hydroxide (Ca(OH)2) (Drug)

Chitosan nano particles (CNPs)

Experimental

intracanal medication in infected root canal

干预措施: chitosan nanoparticles gel (Drug)

control

No Intervention

结局指标

主要结局

Bacterial load.

时间窗: two weeks

Samples will be collected from the infected root canal before and after injection of intracanal medicaments then bacterial colonies will be counted for colony forming units per milliliter (CFU/ml) to assess the effect of the intracanal medicaments used.

次要结局

  • Visual Analogue Scale (VAS) to measure post operative pain level.(12 hours, 24 hours, 48 hours, 72 hours.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana mohamed mustafa nagdy

Dentist

Ain Shams University

研究点 (1)

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