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临床试验/CTRI/2024/06/068447
CTRI/2024/06/068447已完成3 期

A Comparative Evaluation of Antimicrobial Efficacy of Octenidine Dihydrochloride with Chlorhexidine and Sodium Hypochlorite as Root Canal Irrigants: A Randomized Controlled Trial

Guru Nanak Institute of Dental Sciences and Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月11日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Antimicrobial efficacy of Octenidine Dihydrochloride (0.1%) compared to Sodium hypochlorite (2.5%) and Chlorhexidine Digluconate (2%) as a root canal irrigant

研究概览

简要总结

AIM OF THE STUDY

 To evaluate and compare the antimicrobial efficacy of 0.1% Octenidine Dihydrochloride compared to 2.5% Sodium Hypochlorite and 2% Chlorhexidine Digluconate as root canal irrigant.

 MATERIAL AND METHODS

 The study is designed as a prospective, randomized, double blinded clinical trial. 60 patients will be enrolled from the department of Conservative Dentistry and Endodontics who are systemically healthy between the age 15-40 years and fulfilling the inclusion criteria of the study. Patients will be randomly assigned into three groups using systemic random sampling technique.

 Group 1: 0.1% Octenidine Dihydrochloride

Group 2: 2% Chlorhexidine Digluconate

Group 3: 2.5% Sodium Hypochlorite

 Patients and outcome assessor will be blinded to the groups of the study. Chemo-mechanical preparation will be done till F2 Protaper Gold rotary file. And irrigation will be done using three different solutions according to the groups. Then bacterial samples will be collected using paper points before and after the instrumentation. Then Colony forming count will be done to evaluate the efficacy of the different solutions.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients without any systemic disease
  • Tooth with fully formed root
  • Tooth diagnosed with systemic irreversible pulpitis
  • Tooth which does not show tenderness on percussion
  • Tooth with no periapical lesion.

排除标准

  • Patient with systemic disease and co-morbidities
  • Patient with history of medication(antibiotics) 15 days prior to the procedure
  • Tooth with history of previous endodontic treatment
  • Multirooted tooth 5.Non vital tooth
  • Tooth with root caries
  • Tooth with open apex
  • Tooth showing root resorption
  • Tooth with periapical lesion.

结局指标

主要结局

Antimicrobial efficacy of Octenidine Dihydrochloride (0.1%) compared to Sodium hypochlorite (2.5%) and Chlorhexidine Digluconate (2%) as a root canal irrigant

时间窗: Antimicrobial efficacy of Octenidine Dihydrochloride (0.1%) compared to Sodium hypochlorite (2.5%) and Chlorhexidine Digluconate (2%) as a root canal irrigant at baseline, immediately before the chemomechanical preparation and 1 hour after the chemomechanical preparation

次要结局

  • Antimicrobial efficacy of 2.5% Sodium hypochlorite & 2% Chlorhexidine Digluconate(Antimicrobial efficacy of 2.5% Sodium hypochlorite & 2% Chlorhexidine Digluconate at baseline immediately before the chemomechanical preparation & 1 hour after the chemomechanical preparation)

研究者

发起方
Guru Nanak Institute of Dental Sciences and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sahil Ali

Guru Nanak Institute of Dental Sciences and Research

研究点 (1)

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