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临床试验/NCT04481945
NCT04481945已完成4 期

Evaluation of Antimicrobial Efficacy and Adaptability to Root Canal Dentin of Bioceramic Sealer Containing Nanoparticles (In-vitro Study)

Misr International University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Antibacterial efficacy Measuring antibacterial effect of sealers

研究概览

简要总结

Successful endodontic treatment depends primarily on the elimination of infecting microorganisms. This is done by chemo-mechanical preparation of root canals, which is not enough and microorganisms might still survive. Thus, from the main requirements of sealers is to have antibacterial properties and adaptability. Those requirements are needed to kill persisting bacteria after obturation and provide effective seal. Therefore, nanosilver and chitosan inserted to BC sealer and so the antibacterial activity will be assessed on E. faecalis using direct contact test after the setting of the sealer, and the results will be reported using percentage reduction of the colony forming units. Besides, adaptability will be assessed using scanning electron microscope.

详细描述

The main purpose of endodontic therapy is to clean and shape the root canals. This is done by means of instruments and chemical irrigants in order to effectively control the pulpal and periapical infection. That chemomechanical preparation aims to reduce the microorganisms count but cannot completely eliminate it. This is mainly due to (i) anatomical complexity and access limitations (ii) incompetent chemomechanical preparations leaving surfaces untouched (iii) ineffectual irrigation. Besides, despite an accurate chemomechanical preparation, infection may persist in 20-33% of cases, even if intracanal medicament is used.

Treatment failure may also occur due to microleakage, which occurs due to interfacial gaps between the gutta-percha and the sealer, the sealer and the dentin, or through voids within the sealer. Fifty eight percent of treatment failures happen due to incomplete obturation and that's why, hermetic seal is the main factor associated with the success of root canal treatment . Therefore, disinfection, gap-free, three dimensional obturation are the main requisites for treatment standards in endodontics.

Another reason for treatment failure is presence of persisting bacteria. Enterococcus faecalis is a resistant bacterium commonly retrieved from obturated root canals with post treatment disease (apical periodontitis). This pathogen is believed to be highly virulent; it can invade dentinal tubules, adhere, overcome environmental challenges and form biofilm.. Besides, it can resist intracanal disinfectants and medicaments. Therefore, the best approach to resolve this is by using a sealer with broad spectrum antibacterial action.

Ideal root-canal sealer should be able to kill microorganisms on direct contact on the dentinal walls and those present deep inside the dentinal root canals. That means that it should be able to diffuse inside the dentinal tubules to entomb and kill surviving bacteria. Besides, it should be capable of perfectly sealing the prepared canal to block any space and nutrients needed for bacterial growth. Finally, endodontic sealers that retain flowability and antimicrobial properties may help eliminate microorganisms in the root canal system.

Dspite the fact that most sealers have antibacterial constituents, their antibacterial activity is eventually lost after setting. Besides, even if it doesn't, these constituents have to be liberated from the set sealer matrix to fulfill their function. Then again, their release would be accompanied by disintegration of the sealer, interfacial gaps and later on bacterial recolonization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Blinding; Assessor blinding, where both the evaluators and statisticians will be blinded to the treatment groups.

入排标准

性别
All
接受健康志愿者

入选标准

  • Sound extracted anterior without any signs of caries
  • No cracks
  • No resorption or immature apices
  • Single rooted with single canal confirmed radiographically both buccolingually and mesiodistally

排除标准

  • Calcified canals
  • Internal or external resorption
  • Crown or root fractures

研究组 & 干预措施

bioceramic sealer

Active Comparator

pre-mixed bioceramic obturation material. It is dispensed using a syringe in cases of root canal obturation and with either a syringe or as a putty when doing root repair and retrograde fillings.

干预措施: bioceramic sealer (Drug)

bioceramic sealer and silver nanoparticles

Experimental

silver nanoparticles are antibacterial ions that can interact with multiple targets in the bacterial cell

干预措施: bioceramic sealer (Drug)

bioceramic sealer and chitosan

Experimental

chitosan has an excellent antibacterial, antiviral and antifungal properties, as an antibacterial, it works better on gram negative than gram positive

干预措施: bioceramic sealer (Drug)

结局指标

主要结局

Antibacterial efficacy Measuring antibacterial effect of sealers

时间窗: 24 hours

Counting the colony forming units (in-vitro study)

次要结局

  • adaptability(24 hours)

研究者

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

Nourhan Magdy Yehia

Principal investigator

Misr International University

研究点 (1)

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