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临床试验/NCT06172023
NCT06172023已完成不适用

Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm (An in Vitro - in Vivo Study)

Minia University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
Postoperative Pain Assessment

研究概览

简要总结

Silver nanoparticles possess unique physicochemical and biological properties in addition to their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated antibacterial effects against a wide range of bacteria, including heat and pressure resistant spores. Given these characteristics, it would be valuable to evaluate and compare a new irrigation solution containing nanosilver and nanozinc-oxide particles with sodium hypochlorite. Furthermore, Chitosan Nanoparticles are expected to exhibit enhanced antibacterial activity compared to regular-sized Chitosan due to their ability to penetrate and disrupt microbial cell membranes. Consequently, the current study aims to assess and compare the antibacterial activity of Silver Nanoparticles and Chitosan Nanoparticles, as well as their impact on post-operative pain.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically stable healthy patients (category: American society of anesthesiologists class I).
  • The patient ranges in age from 20 to
  • No sexual orientation
  • Necrotic pulp evaluated by thermal or electrical pulp testing.
  • Enough crown structure to provide adequate isolation.
  • One root and one canal.
  • Patients' desire to engage in this research.
  • Patients' comprehension of the visual analogue scale (VAS).
  • Patients' ability to sign informed consent.

排除标准

  • Endodontic treatment for the tooth previously.
  • Teeth with poor conditions for using rubber dams.
  • Vital pulp tissue was observed throughout the treatment.
  • Patients who have a medical condition.
  • Teeth with open apices that are immature
  • Women who are pregnant or breastfeeding.
  • Psychologically disturbed patients.
  • Patients having a history of allergy to any of the research drugs were barred from participation.
  • A periodontally affected tooth with grade 2 or 3 mobility.

研究组 & 干预措施

Silver Nanoparticles Irrigant

Experimental

干预措施: Silver Nanoparticles Irrigant (Drug)

Chitosan Nanoparticle Irrigant

Experimental

干预措施: Chitosan Nanoparticles Irrigant (Drug)

2.6% NaOCl and 17% EDTA sol

Active Comparator

干预措施: Silver Nanoparticles Irrigant (Drug)

2.6% NaOCl and 17% EDTA sol

Active Comparator

干预措施: Chitosan Nanoparticles Irrigant (Drug)

结局指标

主要结局

Postoperative Pain Assessment

时间窗: 6, 12, 24, 48, and 72 hours

Each patient was given a pain scale chart (VAS scale) before every endodontic operation to record his or her pain level. The VAS is a 10-point scale with values ranging from 0 to 10, with 0 representing "No pain," (1-3) representing "mild pain," (4-6) representing "moderate pain," and (7-10) representing "worst imaginable pain." At 6, 12, 24, 48, and 72 hours, each patient was instructed to use the VAS scale (0-10) to rate the presence and severity of discomfort after obturation.

次要结局

  • Antimicrobial Activity Assessment(1 hour, 24 hours, 7 days, and 30 days)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Amr El Wakad

Doctorate candidate at the Faculty of Dentistry, Minia University

Minia University

研究点 (1)

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