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CTRI Number  CTRI/2025/07/091399 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 25/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing the Effectiveness of Three Root Canal Disinfectants in Killing Bacteria During Dental Treatment 
Scientific Title of Study   Quantitative Analysis Of Antibacterial Efficacy Of Octenidine Dihydrochloride, Sodium Hypochlorite and Chlorhexidine Digluconate against Endodontic Microflora: An In-Vivo Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debopratim Panja 
Designation  Post graduate trainee 
Affiliation  Guru nanak institute of dental sciences and research 
Address  2nd floor, Department of Conservative dentistry and Endodontics, Guru Nanak institute of dental sciences and research, 157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata

North Twentyfour Parganas
WEST BENGAL
700114
India 
Phone  9002138367  
Fax    
Email  debopratim17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priti D. Desai 
Designation  Professor 
Affiliation  Guru nanak institute of dental sciences and research 
Address  2nd floor, Department of Conservative dentistry and Endodontics, Guru Nanak institute of dental sciences and research, 157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata

North Twentyfour Parganas
WEST BENGAL
700114
India 
Phone  9831071632  
Fax    
Email  priti.desai@gnidsr.ac.in  
 
Details of Contact Person
Public Query
 
Name  Debopratim Panja 
Designation  Post graduate trainee 
Affiliation  Guru nanak institute of dental sciences and research 
Address  2nd floor, Department of Conservative dentistry and Endodontics, Guru Nanak institute of dental sciences and research, 157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata

Barddhaman
WEST BENGAL
713102
India 
Phone  9002138367  
Fax    
Email  debopratim17@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Debopratim Panja 
Address  2nd floor, Department of conservative dentistry and endodontics, Guru Nanak institute of dental sciences and research, 157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Debopratim panja  Guru nanak institute of dental sciences and research  2nd floor, Department of Conservative dentistry and Endodontics, Guru Nanak institute of dental sciences and research, 157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata
North Twentyfour Parganas
WEST BENGAL 
9002138367

debopratim17@gmail.com 
Dr Debopratim panja  guru nanak institute of pharmaceutical sciences and technology  2nd floor, department of life sciences, guru nanak institute of pharmaceutical sciences and technology, 157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114
North Twentyfour Parganas
WEST BENGAL 
9002138367

debopratim17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Guru Nanak Institute of Dental Sciences & Research Panihati, Kolkata-700114  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine digluconate  Chlorhexidine Digluconate has antimicrobial activity, substantivity and efficient clinical performance. However, evidence from medical field suggests an increase in CHX-resistant bacterial strains. It also exhibits the side effect of cytotoxicity as well as Neurotoxicity. Some studies show it induces tissue necrosis and intense inflammatory response. Chlorhexidine digluconate will be placed inside the root canal for a duration of 5 minutes. 
Intervention  Octenidine dihydrochloride  Octenidine Dihydrochloride is a widely recognized disinfectant in the medical field and has been assessed in numerous in-vitro studies as a potential root canal irrigant, showing promising results in canal disinfection. • Octenidine Dihydrochloride (OCT), created by the Sterling Winthrop Research Institute in 1990, is a bispyridine compound, specifically N,N-[1,10-decanediyldi- 1(4H)-pyridinyl-4-ylidene] bis(l-octanamine) dihydrochloride. • OCT possesses a broad-spectrum antimicrobial profile effective against Gram-positive and Gram-negative bacteria, fungi, and certain viral species. Octenidine dihydrochloride will be placed inside the root canal for a duration of 5 mins. 
Comparator Agent  Sodium hypochlorite  Sodium hypochlorite (NaOCl) is among the most commonly used irrigants in this procedure. NaOCl has strong antibiofilm properties and can dissolve organic tissue effectively. However, it can cause significant irritation if it contacts periapical tissues, has an unpleasant odor and taste, and may cause allergic reactions in some patients. Additionally, Sodium Hypochlorite may alter the mechanical properties of dentin, affecting its microhardness, modulus of elasticity, and flexural strength, and it may weaken the bond strength of root canal sealers. Sodium hypochlorite will be placed inside the root canal for a duration of 5 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the antimicrobial efficacy of three root canal irrigants — Octenidine dihydrochloride, Sodium hypochlorite, and Chlorhexidine digluconate— against endodontic microflora.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the microbial load in root canals before & after treatment with each irrigant using the colony-forming unit (CFU) method.
 
At baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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