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CTRI Number  CTRI/2019/12/022399 [Registered on: 17/12/2019] Trial Registered Prospectively
Last Modified On: 30/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   ANTIMICROBIAL EFFECTIVENESS OF DIFFERENT IRRIGATING SOLUTIONS IN ROOT CANAL SYSTEM 
Scientific Title of Study   “COMPARATIVE EVALUATION OF ANTIMICROBIAL EFFECTIVENESS OF SODIUM HYPOCHLORITE ,CALCIUM HYPOCHLORITE AND MORINDA CITRIFOLIA AGAINST MICROORGANISMS PRESENT IN THE ROOT CANAL SYSTEM” : A RANDOMIZED CONTROLLED TRIAL. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ANITH KUMAR CHAKILELA 
Designation  PG STUDENT 
Affiliation  KAMINENI INSTITUTE OF DENTAL SCIENCES 
Address  Department of Conservative dentistry and Endodontics, Kamineni Institute of Dental Sciences, Sreepuram, Narketpally Nalgonda,Telangana.

Nalgonda
TELANGANA
508254
India 
Phone  9573130353  
Fax    
Email  anithget2me@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR S JAYAPRADA REDDY 
Designation  PROFFESOR 
Affiliation  KAMINENI INSTITUTE OF DENTAL SCIENCES 
Address  Department of Conservative dentistry and Endodontics, Kamineni Institute of Dental Sciences, Sreepuram, Narketpally

Nalgonda
TELANGANA
508254
India 
Phone  9703936020  
Fax    
Email  drsjayapradareddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR S JAYAPRADA REDDY 
Designation  PROFFESOR 
Affiliation  KAMINENI INSTITUTE OF DENTAL SCIENCES 
Address  Department of Conservative dentistry and Endodontics, Kamineni Institute of Dental Sciences, Sreepuram, Narketpally

Medchal
TELANGANA
508254
India 
Phone  9703936020  
Fax    
Email  drsjayapradareddy@gmail.com  
 
Source of Monetary or Material Support  
Kamineni institute of dental sciences.Narketpally,nalgonda 
 
Primary Sponsor  
Name  DR CH ANITH KUMAR 
Address  Department of Conservative dentistry and Endodontics, Kamineni Institute of Dental Sciences, Sreepuram, Narketpally Nalgonda, Telangana.  
Type of Sponsor  Research institution 
 
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 Ch Anith Kumar  Kamineni institute of dental sciences.  Room no 121 , Department of conservative dentistry and endodontics, narketpally, nalgonda.
Nalgonda
TELANGANA 
9573130353

anithget2me@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, KIDS , Narketpally  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  In need of root canal therapy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Calcium hypochlorite  10 ml Calcium hypochlorite in root canal for 60 seconds 
Comparator Agent  Morinda citrifolia  10ml of Morinda citrifolia in rootcanal for 60 seconds 
Intervention  Sodium hypochlorite  10ml Sodium hypochlorite in rootcanal for 60 sec 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Patients aged between 18-55 years
2.Teeth with necrotic pulp.
3.Patient requiring endodontic therapy.
4.Healthy patients without systemic disease.
5.Teeth with asymptomatic/symptomatic apical periodontitis.
 
 
ExclusionCriteria 
Details  1.Crown and root fracture.
2.Grossly decayed tooth.
3.Vital teeth.
4.Medically compromised patients.
5.Para functional habits.
6.Non carious lesions.
7.TMJ disorders
8.Patients on antibiotic therapy.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Antimicrobial effectiveness  Pre treatment and Post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Pulp dissolution  Pre treatment and Post treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/12/2019 
Date of Study Completion (India) 03/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The successful outcome of endodontic treatment depends on through disinfection. Based on this concept, the ultimate goal of endodontic therapy is to eliminate or remarkably minimize the microbes and their toxic products from the root canal before obturation.

However the complex morphology of root canal system, invasion of microbes into the dentinal tubules, and formation of smear layer during instrumentation are the major obstacles in achieving complete cleaning and shaping of the root canals.The role of mechanical instrumentation alone in removing microbes from the root canals has been investigated in many studies, and majority of them have found a significant reduction in the microbial count with an increasing preparation size and irrigation However, Peter and Wesselink found that more than 35% of root canal walls remained untouched even by modern rotary Ni‑Ti instrumentation techniques.

Sodium hypochlorite is the gold standard and the most effective irrigating solution but owing to the potential side effects, constant increase in antibiotic strains, safety concerns and cytotoxic reactions there is a need for an alternative.

Calcium hypochlorite is antimicrobial, relatively more stable, higher available chlorine ion percentage and induces minimal inflammatory response when compared to Sodium hypochlorite.

Due to increased cytotoxic reactions of synthetic irrigants, usage of various herbal agents has increased over the last few decades.

Morindacitrifolia juice (MCJ) commercially known as Noni juice exhibits antiviral, antifungal, antihelminthic, antitumor, anti-inflammatory, analgesic,hypotensive, and immune-enhancing effect suggesting its potential to be used as an endodontic irrigant. 
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