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临床试验/NCT07420920
NCT07420920尚未招募1 期

Assessment of the Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of Sodium Hypochlorite: A Randomized Clinical Trial

Misr University for Science and Technology0 个研究点目标入组 36 人开始时间: 2026年2月10日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
36
主要终点
Bacterial reduction

研究概览

简要总结

The goal of this clinical trial is to is to assess the antibacterial effect of sodium hypochlorite heated inside root canals of necrotic teeth using various activation techniques

The main question it aims to answer is:

Does the antibacterial effect vary following various standardized techniques of intracanal heating of sodium hypochlorite in endodontic treatment?

详细描述

Root canal treatment success depends on the removal of necrotic and vital pulp tissues and bacteria and bacterial byproducts from the root canal system.

Mechanical cleansing and removal of necrotic or vital pulp tissue lead to the formation of a layer of debris called " Smear layer," which is made of organic and inorganic substances that should be removed from the root canal system with the help of irrigants.

The presence of complex anatomy like isthmi and anastomoses makes chemical cleansing of the root canal system difficult because they are filled with the smear layer.

The ideal features of root canal irrigants include cleansing, lubrication of endodontic instruments and root canal system, dissolution of inorganic and organic tissues, antimicrobial properties, absence of cytotoxicity without alteration of dental microstructure. Sodium hypochlorite (NaOCl) has been the most widely used irrigant in endodontics due to its antimicrobial and tissue-dissolving action.

Due to the presence of complex anatomy inside the root canal system, activation of irrigation is essential to improve the cleaning of such a complex system. Ultrasonic activation is presently the most popular method for activation of irrigation. It delivers the irrigant farther into areas of the root canal system untouched by instruments, and it improves the mechanical cleaning by increasing the wall shear stress.

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

性别
All
接受健康志愿者

入选标准

  • For patients:
  • adult male or female patients
  • medically free.
  • For selected teeth:
  • asymptomatic necrotic single rooted teeth
  • teeth with mature root
  • restorable teeth.

排除标准

  • For patients:
  • Patients with dental related symptoms
  • patients with chronic or systemic diseases
  • pregnant females.
  • For selected teeth:
  • multirooted teeth
  • vital teeth
  • teeth with incompletely formed roots
  • teeth with internal or external resorption
  • previously root canal treated teeth

研究组 & 干预措施

Intracanal heating for activation using System-B heat carrier

Experimental

干预措施: System-B (Device)

Intracanal heating for activation using ultrasonics

Active Comparator

干预措施: Ultrasonic activation (Device)

Intracanal heating for activation using a combination of ultrasonics and System-B

Experimental

干预措施: System-B (Device)

Intracanal heating for activation using a combination of ultrasonics and System-B

Experimental

干预措施: Ultrasonic activation (Device)

结局指标

主要结局

Bacterial reduction

时间窗: after treatment, samples are sent to microbiology lab and bacterial count is measured day 1 after treatment.

Antibacterial effect is evaluated by counting number of bacterial colonies, samples are collected and placed in brain-heart infusion (BHI) broth and subjected to microbiological analysis to determine the colony-forming unit (CFU)/ml

次要结局

  • Post-operative pain(Post operative pain is measured until day 3 after treatment)

研究者

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

Alaa El din Yasser Mohamed Salah Eldin

Dr

Misr University for Science and Technology

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