| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - In the form of informed Consent
- 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.
- 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. |