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临床试验/NCT05964686
NCT05964686已完成2 期

The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial

Future University in Egypt2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Quantitative microbiological analysis

研究概览

简要总结

The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

  • Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  • Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  • Group C(Combined): saline along with 17% EDTA and diode laser combination Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.

详细描述

The use of lasers in disinfection of the root canal has been recently implemented. Lasers have bactericidal effect, and have deep penetration depth inside the root canal up to 1000 um. Thus, it can be used effectively for disinfection of the root canal system following biomechanical instrumentation reaching areas which were considered before non-reachable.

The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

  • Group A (Conventional): 2.5% NaOCL and 17% EDTA.
  • Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
  • Group C(Combined): saline along with 17% EDTA and diode laser combination After disinfection, local anesthetic and tooth isolation and access cavity preparation, the first microbial samples (S1) will be collected using 3 sterile paper points and immediately placed inside sterile tubes containing transport medium of thioglycolate, cleaning and shaping with final disinfection protocol will be performed according to the group in which the participant was allocated to. Followed by S2 sample. obturation using warm vertical compaction technique. Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.

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
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients who are medically free.
  • Patient's age between 18-35 years.
  • One single rooted maxillary anterior tooth with necrotic pulp and asymptomatic apical periodontitis requiring root canal treatment.
  • Patients complaining of no pain and without fistulous tract.
  • Periapical lesion with a periapical index score of 3 or 4 (Ørstavik, et al. (1986)108
  • Closed apex.
  • Acceptance to participate in the study.

排除标准

  • Patients suffering from any systemic disease.
  • Patients who had received antibiotics during the last month.
  • Patients taking analgesics 12 hours before interventions.
  • Patients with history of tobacco usage
  • Teeth with vital pulp, calcified canals, and immature or incompletely formed apices.
  • Teeth with previous endodontic treatment.
  • Non restorable teeth where rubber dam could not be applied.
  • Teeth with periodontal pocket more than 3 mm.
  • Teeth with greater than grade 1 mobility.
  • Teeth with swelling/sinus tract.
  • Technical difficulties in the course of root canal treatment for example:
  • A tooth with curved roots

结局指标

主要结局

Quantitative microbiological analysis

时间窗: baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]

aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml). anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).

次要结局

未报告次要终点

研究者

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

Sara Zakaria Fahim

assistant lecturer

Future University in Egypt

研究点 (2)

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