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临床试验/NCT03853200
NCT03853200已完成2 期

In-vivo Comparison of Antibacterial Efficacy of Three Different Solutions as Final Irrigant During Endodontic Therapy: A Randomized Controlled Trial

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年4月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Change in Colony forming Unit

研究概览

简要总结

This study was conducted to determine the antibacterial affect of three different solutions used as final irrigant during endodontic therapy. The investigator's objective was to compare the antibacterial affect of relatively new final irrigant QMix with EDTA and Qmix with EDTA+CHX by evaluating the bacteriological status of the root canal before and after use of the final irrigant.

详细描述

The aim of this clinical trial is to compare the antibacterial efficacy of Qmix, to 17% EDTA+ Chlorhexidine and 17% EDTA, used as final irrigants, during endodontic procedure.

Endodontic treatment was carried out on 90 necrosed teeth of patients under rubber dam isolation and strict sterilization protocol. The teeth were divided into three groups; A, B and C depending on the type of final irrigant to be used. The chemo-mechanical preparation of all the 90 samples was carried out using ProTaper Universal (Dentsply) File system, and 3% sodium Hypochlorite. All the samples from each group were then irrigated according to the final rinse protocol (FRP). Group A was irrigated with Qmix; Group B with 17% EDTA + 2% Chlorhexidine and Group C (Control group) 17% EDTA.

Three bacteriologic samples were taken during the procedure from each root canal under study in all three groups, using sterile paper points. Sample A was collected after access cavity opening and negotiation of the canal but before chemo-mechanical preparation. Sample B was taken after chemo-mechanical preparation but before the use of the final irrigant. Sample C was collected after the use of final irrigation solution. The samples were collected with sterile paper points and were then transferred to microbiology laboratory in microtubes containing Brain Heart Infusion (BHI) broth within 2 hours of sample collection for obtaining the colony forming unit (CFU) counts.

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

  • Single rooted (One root canal)
  • Necrosed teeth requiring root canal treatment.
  • Teeth with mature apices
  • Permanent dentition
  • Mandibular & Maxillary
  • PAI category 1 to 4

排除标准

  • Single rooted teeth with multiple canals
  • Root canal treated
  • Requiring elective endodontic therapy
  • With partial necrosis
  • Fractured
  • Having calcified and obliterated canals.
  • Having root resorption
  • Root canals which could not be negotiated to full working length with #10 K file
  • Having severe periodontitis with exacerbating features (PAI = 5)
  • Having grade III mobility
  • Patients who took systemic antibiotics in past four weeks.

研究组 & 干预措施

Group I

Experimental

QMix the solution under investigation which includes CHX EDTA and detergent QMix Root Canal Irrigant

干预措施: QMix Root Canal Irrigant (Drug)

Group II

Active Comparator

it involves use of two irrigant solutions, 17%EDTA+2%Chlorhexidine

干预措施: 17%EDTA+2%Chlorhexidine (Drug)

Group III

Active Comparator

17% EDTA with no antibacterial activity . the control group

干预措施: EDTA (Other)

结局指标

主要结局

Change in Colony forming Unit

时间窗: Before and after use of final irrigant, up to 5 minutes

Change in the Colony forming unit (CFU) of the root canal sample will be assessed by determining the difference between Mean CFU of sample taken before use of final irrigant and sample taken after use of final irrigant.

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

Hasan Afaq Zaidi

Principal Investigator

Dow University of Health Sciences

研究点 (1)

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