| 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
|
|
|
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
|
|
|
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. |