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临床试验/CTRI/2026/02/104223
CTRI/2026/02/104223尚未招募不适用

Comparative evaluation of chlorhexidine and antibiotic combination irrigants containing amoxyclav, ciprofloxacin and metronidazole for root canal disinfection An in vivo study

Dr Priya Naikwade1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1

研究概览

简要总结

Root canal infections are polymicrobial in nature and are a major cause of failure of endodontic treatment. Mechanical instrumentation alone is insufficient to completely eliminate microorganisms from the complex root canal anatomy, necessitating the use of effective irrigating solutions. Chlorhexidine is a commonly used irrigant due to its broad-spectrum antimicrobial activity and substantivity; however, it lacks tissue-dissolving properties and may be less effective against resistant microorganisms. Antibiotic combinations such as amoxyclav, ciprofloxacin, and metronidazole offer broader antimicrobial coverage and may enhance root canal disinfection.This randomized controlled clinical trial aims to comparatively evaluate the antimicrobial efficacy of 2% chlorhexidine, 2% chlorhexidine with metronidazole (0.5%), amoxyclav (1.2 g) with metronidazole (0.5%), and ciprofloxacin (0.2%) with metronidazole (0.5%) as root canal irrigants. A total of 60 patients requiring primary root canal treatment in single-rooted permanent teeth diagnosed with pulp necrosis and/or chronic apical periodontitis will be recruited and randomly allocated into four groups. All cases will undergo standardized chemomechanical preparation using 5.25% sodium hypochlorite and 17% EDTA, followed by final irrigation with the assigned study solution.Microbiological samples will be collected before and after irrigation using sterile paper points, and intracanal bacterial load will be assessed by culture techniques and expressed as colony-forming units per milliliter (CFU/ml). The primary outcome measure will be the reduction in intracanal microbial load, while secondary outcomes will include intergroup comparison of antimicrobial efficacy, percentage reduction in bacterial counts, reduction in Enterococcus faecalis, and incidence of adverse events. The results of this study may help identify a more effective irrigation regimen for enhanced root canal disinfection.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1.Diagnosed with pulpal and peri radicular diseases.
  • 2.Patients indicated for root canal treatment.
  • 3.Patients willing to comply with Study protocol and Follow-up visits.

排除标准

  • 1.Patients with Systemic diseases affecting immunity or wound healing 2.Patients with history of antibiotic intake within the previous 4 weeks.
  • 3.Teeth with Previous root canal treatment, Open apex, immature roots, or incomplete root formation,Internal or external root resorption, Root fractures or cracks,Calcified canals or severely curved canals.

研究者

发起方
Dr Priya Naikwade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Priya Naikwade

Saraswati Dhanwantari Dental college, Parbhani

研究点 (1)

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