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CTRI Number  CTRI/2017/07/009015 [Registered on: 11/07/2017] Trial Registered Prospectively
Last Modified On: 07/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Disinfection achieved during root canal treatment by 2 disinfecting agents -bromelain (pineapple stem extract), and sodium hypochlorite (the current treatment standard). 
Scientific Title of Study   “Comparison of anti-microbial efficacy of Bromelain extract and Sodium hypochlorite used as root canal irrigant in primary root canal treatment: a Randomized Controlled Clinical trial”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1196-5991  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sherin Jose Chockattu 
Designation  Senior Lecturer 
Affiliation  Bapuji Dental College & Hospital 
Address  No. 6, Dept of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, MCC-B Block, Davangere, Karnataka - 577004, India

Davanagere
KARNATAKA
577004
India 
Phone  9535542942  
Fax    
Email  sherinjose.com@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sherin Jose Chockattu 
Designation  Senior Lecturer 
Affiliation  Bapuji Dental College & Hospital 
Address  No. 6, Dept of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, MCC-B Block, Davangere, Karnataka - 577004, India


KARNATAKA
577004
India 
Phone  9535542942  
Fax    
Email  sherinjose.com@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sherin Jose Chockattu 
Designation  Senior Lecturer 
Affiliation  Bapuji Dental College & Hospital 
Address  No. 6, Dept of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, MCC-B Block, Davangere, Karnataka - 577004, India


KARNATAKA
577004
India 
Phone  9535542942  
Fax    
Email  sherinjose.com@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences (RGUHS), 4th T Block, Jayanagar, Bengaluru, Karnataka - 560041. 
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  4th T Block, Jayanagar, Bengaluru, Karnataka - 560041. 
Type of Sponsor  Government funding agency 
 
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 
Sherin Jose Chockattu  Bapuji Dental College and Hospital  No. 6, Dept of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, MCC-B Block, Davangere, Karnataka - 577004, India
Davanagere
KARNATAKA 		 9535542942
9535542942
sherinjose.com@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Development & Sustenance Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Infected root canals (irreversible pulpitis or necrotic pulp with apical periodontitis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bromelain  Non-toxic proteolytic agent, already in use in medicine for treatment of burn wounds -- to remove necrotic tissue, whilst preserving healthy vital tissue. Has properties favourable for its use as a root canal disinfectant (irrigant) -- proteolytic, antimicrobial, biocompatible. 
Comparator Agent  Sodium hypochlorite  The standard irrigant used for disinfection in root canals, but have inferior biocompatibility. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Maxillary or mandibular, incisors or canines; Endodontic diagnosis of irreversible pulpitis/ necrotic pulp, with apical periodontitis. 
 
ExclusionCriteria 
Details  Previous endodontic treatment; Post-endodontic restoration not feasible; Intentional RCT; Vital pulp requiring RCT due to contraindication of vital pulp therapy.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Microbial analysis (change in Colony forming units).  1. Pre-operative microbial sampling;
2. Post-disinfection microbial sampling.
There is no follow-up. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2 
Date of First Enrollment (India)   01/12/2017 
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="6"
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)?  

Brief Summary  
This is a clinical study proposed to be conducted during routine root canal treatment. Disinfection is conventionally achieved by an irrigant called sodium hypochlorite. This agent has antimicrobial and pulp dissolving action, but suffers from inferior biocompatibility to soft tissues. The proposed irrigant is Bromelain, a non-toxic pineapple-derived proteolytic enzyme. Its antimicrobial effects have been established in-vitro, and it has been used in patients with burn injury to remove necrotic tissue, while not harming the vital soft tissues. It has also been used as an anti-inflammatory agent after tooth extraction. It is also economical, being comparable to sodium hypochlorite.
In this study, the antimicrobial efficacy will be assessed clinically, comparing the disinfection efficacy of sodium hypochlorite and bromelain. 
The clinical study will be presented to the Institutional Review Board of the college. Awaiting this approval, an application will be sent for a research grant to the university. Once grants are obtained, the recruitment of patients (out-patients) will begin. 
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