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CTRI Number  CTRI/2026/02/104223 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 16/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of commonly used disinfecting solutions in root canal treatment 
Scientific Title of Study   Comparative evaluation of chlorhexidine and antibiotic combination irrigants containing amoxyclav, ciprofloxacin and metronidazole for root canal disinfection 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  Dr Priya Naikwade 
Designation  PG student 
Affiliation  Saraswati Dhanwantari Dental college, Parbhani 
Address  Department of conservative Dentistry and Endodontics,5, Saraswati Dhanwantari Dental College and Hospital, Pathri Road,Parbhani

Parbhani
MAHARASHTRA
431401
India 
Phone  9921543567  
Fax    
Email  priyanaikwade05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharat Deosarkar 
Designation  Professor 
Affiliation  Saraswati Dhanwantari Dental college, Parbhani 
Address  Department of conservative Dentistry and Endodontics,5, Saraswati Dhanwantari Dental College and Hospital, Pathri Road,Parbhani

Parbhani
MAHARASHTRA
431401
India 
Phone  9975581234  
Fax    
Email  deosarkar.bharat16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bharat Deosarkar 
Designation  Professor 
Affiliation  Saraswati Dhanwantari Dental college, Parbhani 
Address  Department of conservative Dentistry and Endodontics,5, Saraswati Dhanwantari Dental College and Hospital, Pathri Road,Parbhani

Parbhani
MAHARASHTRA
431401
India 
Phone  9975581234  
Fax    
Email  deosarkar.bharat16@gmail.com  
 
Source of Monetary or Material Support  
Department of conservative Dentistry and Endodontics,5, Saraswati Dhanwantari Dental College and Hospital, Pathri Road, Parbhani 431401, Maharashtra,India 
 
Primary Sponsor  
Name  Dr Priya Naikwade 
Address  Department of conservative Dentistry and Endodontics,5, Saraswati Dhanwantari Dental College and Hospital, Pathri Road,Parbhani,431401 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priya Naikwade  Saraswati Dhanwantari Dental College and Hospital  Department of conservative Dentistry and Endodontics,5, Saraswati Dhanwantari Dental College and Hospital, Pathri Road,Parbhani
Parbhani
MAHARASHTRA 
9921543567

priyanaikwade05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDDC PBN IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amoxyclav + Metronidazole Group  After standardized chemomechanical preparation, canals will be irrigated using amoxyclav (1.2 g) and 0.5 %metronidazole combination irrigant solution(5 ml) for 2 Minutes. 
Comparator Agent  Chlorhexidine Group  After standardized chemomechanical preparation using 5.25% sodium hypochlorite and 17% EDTA, root canals will be finally irrigated using 2% chlorhexidine gluconate solution (5 ml) for 2 Minutes. 
Intervention  Chlorhexidine+ Metronidazole Group  After standardized chemomechanical preparation, canals will be irrigated using a combination solution of 2% chlorhexidine and 0.5% metronidazole(5 ml) for 2 Minutes. 
Intervention  Ciprofloxacin + Metronidazole Group  After standardized chemomechanical preparation, canals will be irrigated using 0.2% ciprofloxacin and 0.5% metronidazole combination solution(5 ml) for 2 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in intracanal microbial load (expressed as colony forming units per milliliter, CFU/ml) from baseline to post-irrigation following use of chlorhexidine and antibiotic combination irrigants.  Day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Intergroup comparison of antimicrobial efficacy among chlorhexidine and antibiotic combination irrigants.  Day 1 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   28/02/2026 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  In the form of informed Consent

  6. For how long will this data be available start date provided 25-02-2026 and end date provided 01-01-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

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.

 
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