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CTRI Number  CTRI/2025/04/084606 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluating the level of bacterial reduction during re root canal treatment after the use of 2 percentage Chlorhexidine and modified triple antibiotic paste as root canal medicament 
Scientific Title of Study   Comparative evaluation of bacterial reduction at various stages of Endodontic Retreatment after the use of 2 percentage Chlorhexidine gel and modified triple antibiotic paste as Intracanal medicaments - A Non-Randomized Clinical Trial Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adithya Kashyap 
Designation  1st Year Post Graduate Student 
Affiliation  Yenepoya Dental College 
Address  Yenepoya dental college, yenepoya university, University road, Deralakatte, Mangalore, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  adithyaanu1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Harish S Shetty 
Designation  Professor 
Affiliation  Yenepoya Dental College 
Address  Dept of Conservative dentistry & Endodontics Yenepoya dental college, yenepoya university, University road, Deralakatte, Mangalore, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  shettyharish@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Adithya Kashyap 
Designation  1st Year Post Graduate Student 
Affiliation  Yenepoya Dental College 
Address  Yenepoya dental college, yenepoya university, University road, Deralakatte, Mangalore, Dakshina Kannada, Karnataka


KARNATAKA
575018
India 
Phone    
Fax    
Email  adithyaanu1998@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya Dental College Yenepoya Deemed to be University Deralakatte, Mangalore - 575018 Dakshina Kannada Karnataka India 
 
Primary Sponsor  
Name  Adithya Kashyap 
Address  Dept of Conservative dentistry and endodontics, Yenepoya Dental College, Mangalore 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
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 Adithya Kashyap   Yenepoya Dental College  Department of conservative dentistry and endodontics 2nd floor yepoya Dental College, Yenepoya University, University road, Deralakatte, Mangalore - 575018
Dakshina Kannada
KARNATAKA 
9108276520

adithyaanu1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endodontic Retreatment   Patients in intervention will be divided into 2 study groups as group 1 getting 2 percentage Chlorhexidine gel as intracanal medicament and group 2 getting modified triple antibiotic paste as intracanal medicament during non surgical endodontic retreatment procedure. 
Comparator Agent  Group 1 - 2 percentage Chorhexidine gel as intracanal medicament   2% chlorhexidine gel will be placed as intracanal medicament in the canal using a flexi tip 
Comparator Agent  Group 2 - modified triple antibiotic paste  freshly prepared modified triple antibiotic paste ( consisting of Metronidazole, Ciprofloxacin and Clindamycin) is placed in the canal using paste carrier 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1- Single root filled teeth indicated for non surgical endodontic retreatment procedure as assessed with clinical and radiographical signs
2- root canal treatment completed more than 2years ago 
 
ExclusionCriteria 
Details  1- Patients with history of antibiotic treatment usage in the last 3 months
2- patients reporting with systemic disease starting with ASA grade 3 and above
3- teeth in which rubber dam application for isolation is not feasible
4- Teeth with periodontal pocket depth more than 3mm 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduced bacterial count after the use of 2% Chlorhexidine gel as well as after the use of modified triple antibiotic paste  on 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Comparation between 2% chlorhexidine gel and modified triple antibiotic paste  7th day 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/04/2025 
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="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Favorable outcome of non surgical endodontic retreatment depends on the complete elimination of the microflora from the root canal system. But the conventional chemo-mechanical cleaning and shaping (i.e; using file system and irrigants) may not be successful enough to eliminate the flora and therefore needs the addition of suitable intracanal medicament along with the conventional cleaning and shaping. The most commonly used Intracanal medicament is Calcium hydroxide, which is been used from a long time. But, Calcium hydroxide has several drawbacks such as: The high pH (11 to 12) might be toxic to the periapical gem cells, Inability/ resistance of many microorganisms against calcium hydroxide etc. Therefore, this necessitates the need for a better and more efficient intracanal medicament during retreatment procedures. The proposed study is an interventional study which will be done to evaluate and compare the level of  bacterial reduction between 2 intracanal medicaments: 2% Chlorhexidine gel and modified triple antibiotic paste during non surgical endodontic retreatment. 26 participants will be divided randomly into 2 study groups: group I will be getting 2% Chlorhexidine gel as the Intracanal medicament and group II will be getting freshly prepared modified triple antibiotic paste. Three samples from each participants will be collected during various stages of the retreatment procedure and sent for colony count calculation and evaluating the reduction in bacterial count.

 
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