跳至主要内容
临床试验/CTRI/2025/07/091399
CTRI/2025/07/091399招募中不适用

Quantitative Analysis Of Antibacterial Efficacy Of Octenidine Dihydrochloride, Sodium Hypochlorite and Chlorhexidine Digluconate against Endodontic Microflora: An In-Vivo Study

Debopratim Panja2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
To evaluate and compare the antimicrobial efficacy of three root canal irrigants — Octenidine dihydrochloride, Sodium hypochlorite, and Chlorhexidine digluconate— against endodontic microflora.

研究概览

简要总结

Endodontic treatment, commonly known as root canal therapy,

aims to eliminate infection and prevent reinfection of the dental

pulp and surrounding tissues. The process involves cleaning and

disinfecting the tooth’s interior, followed by filling and sealing it

with a restorative material in a three-dimensional manner. The

disinfection process entails mechanical instrumentation along

with the application of irrigating solutions and intracanal

medicaments. A variety of root canal irrigants have been

employed to achieve optimal outcomes, including normal saline,

oxidizing agents like hydrogen peroxide, chelating agents such

as EDTA, sodium hypochlorite, chlorhexidine, and several

natural substances like Triphala and green tea. Of these, the

most frequently used irrigating solutions are sodium

hypochlorite and chlorhexidine.

Although both chemicals have demonstrated potential as root

canal irrigants, they come with certain drawbacks. This

highlights the need for further research to identify new

chemicals that could serve as effective alternatives for root canal

irrigation.

A range of antimicrobial disinfectants used in medicine has been

assessed for their potential as endodontic irrigants, among these

is Octenidine Dihydrochloride . Multiple in-vitro studies

have examined the antimicrobial effectiveness of Octenidine

Dihydrochloride in comparison to other widely used root canal

irrigants, with promising results. These studies suggest that this

chemical could be a viable irrigant for use in patients’ mouth

during endodontic treatment. Moreover, microorganisms that resists root canal treatment exist

in low numbers in the root canal or can be located in areas of

difficult access to paper points used for sampling. Thus, a low

number of microbial cells may be collected and if less sensitive

methods are used for identification these organisms pass

unnoticed and their prevalence in failed cases can be over

shadowed. Polymerase chain reaction has advantages of

being tremendously sensitive and possibly less affected by

chemical factors such as remnants of medications that can enter

a sample and inhibit the microbial growth in the laboratory. This

method can also detect the occurrence of fastidious or even

uncultivable bacterial species in endodontic infections including

the cases of secondary persistent infections associated with

failed endodontic therapy. Epidemiological studies investigating

the microbiota of root canal treated teeth have revealed that

Enterococcus faecalis is the most commonly detected species

associated with treatment failures irrespective of the method

used for identification.

Despite the existing literature on these agents, there remains a

need for comparative studies assessing their antibacterial

efficacy against endodontic microflora in vivo. Such research is

crucial for understanding the effectiveness of these agents in

clinical scenarios and guiding endodontic treatment protocols.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patient with age group of 18 to 50 years Single root teeth with fully formed root apices.
  • Cases of non-vital asymptomatic apical periodontitis.
  • No history of previous endodontic treatment on the desired tooth Patients who have not been under any antibiotic medications in last 3 months.

排除标准

  • Medically compromised patients, with the exception of those with hypertension, well-controlled diabetes mellitus, or a history of myocardial infarction without an episode in the past six months.
  • Re – treatment endodontic cases Grossly mutilated tooth Calcified canals Tooth with wide or open apex Patients who serve on antibiotic medications during the last 3 months.

结局指标

主要结局

To evaluate and compare the antimicrobial efficacy of three root canal irrigants — Octenidine dihydrochloride, Sodium hypochlorite, and Chlorhexidine digluconate— against endodontic microflora.

时间窗: At baseline

次要结局

  • To determine the microbial load in root canals before & after treatment with each irrigant using the colony-forming unit (CFU) method.

研究者

发起方
Debopratim Panja
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Debopratim Panja

Guru nanak institute of dental sciences and research

研究点 (2)

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