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CTRI Number  CTRI/2024/05/067273 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 18/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of ability of two herbal products used for cleaning root canals in tooth infections. 
Scientific Title of Study   Evaluation of anti microbial efficacy of two herbal products used as irrigants in primary endodontic infections in single rooted teeth - A Randomised Controlled Trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  R BOOBALAN 
Designation  Junior Resident (M.D.S,) 
Affiliation  Government Dental College Kottayam 
Address  Room.no.401 Department of Conservative Dentistry And Endodontics Government Dental College Gandhinagar P.O. Kottayam

Kottayam
KERALA
686008
India 
Phone  9884840017  
Fax    
Email  alanbrave05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SHEENA P 
Designation  Associate Professor 
Affiliation  Government Dental College Kottayam 
Address  Room no.401 Department of Conservative Dentistry And Endodontics Government Dental College Gandhinagar P.O. Kottayam

Kottayam
KERALA
686008
India 
Phone  9847632380  
Fax    
Email  sheenababu.p@gmail.com  
 
Details of Contact Person
Public Query
 
Name  R BOOBALAN 
Designation  Junior Resident (M.D.S,) 
Affiliation  Government Dental College Kottayam 
Address  Room no.401 Department of Conservative Dentistry And Endodontics Government dental college Gandhinagar P.O. Kottayam

Kottayam
KERALA
686008
India 
Phone  9884840017  
Fax    
Email  alanbrave05@gmail.com  
 
Source of Monetary or Material Support  
Government Dental Kottayam Room no.401 Department of Conservative Dentistry and Endodontics Gandhinagar P.O. Kottayam 
 
Primary Sponsor  
Name  R BOOBALAN 
Address  Room no.401 Department of Conservative Dentistry And Endodontics Government Dental College Gandhinagar P.O Kottayam. 
Type of Sponsor  Other [Self] 
 
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 R BOOBALAN   Government Dental College, Kottayam  Room no.401 Department of Conservative Dentistry And Endodontics Gandhinagar P.O Kottayam 686008
Kottayam
KERALA 
9884840017

alanbrave05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of decision of the Institutional Ethics Committee (IEC)/Institutional Review Board (IRB)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% Chlorhexidine Gluconate   Each tooth will be anesthetized and isolated with a rubber dam followed by caries removal. The access cavity will be prepared using a high-speed endo access bur. The working length (WL) will be determined radiographically using RVG by placing a size #10 K-file. Irrigation will be done with 6 mL 2% Chlorhexidine Gluconate. 
Intervention  Neem Juice extract(Azadirachta indica)and Moringa Juice Extract(Moringa olifera).  Each tooth will be anesthetized and isolated with a rubber dam followed by caries removal. The access cavity will be prepared using a high-speed endo access bur. The working length (WL) will be determined radiographically using RVG by placing a size #10 K-file. Irrigation will be done with 6 mL Neem Juice extract (Azadirachta indica). 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Teeth with necrotic or infected pulp diagnosed clinically and radiographically
Teeth with an adequate coronal structure. 
 
ExclusionCriteria 
Details  Patients with systemic conditions, acute periapical abscess, retreatment cases, root fractures
Teeth with calcified canals, sinus opening in mature apexes
Internal or external resorption  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Count of colony forming units before treatment.  Within 1hr of sample collected 
 
Secondary Outcome  
Outcome  TimePoints 
Count of colony forming units after treatment   Within 1hr of sample collected 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 4 
Date of First Enrollment (India)   19/06/2024 
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="1"
Months="1"
Days="1" 
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 - NO
Brief Summary   purpose of this study is to comparatively evaluate antimicrobial efficacy of two herbal products neem and moringa extract used as irrigants with chlorhexidine in primary endodontic infections in single rooted teeth.
Each tooth will be anesthetized and isolated with a rubber dam followed by caries removal. The access cavity will be prepared using a high-speed endo access bur. The working length (WL) will be determined radiographically using RVG by placing a size #10 K-file. The patients will be randomly divided into three groups: Group I: 2% chlorhexidine gluconate (CHX), Group II: Neem juice extract (Azadirachta indica), Group III: moringa juice extract (Moringa olifera).Pretreatment sample (S1) will be obtained by using a sterile paper point immersed in transport media first followed by placing it into the canal for 60secs and then transferred to the test tubes containing transport media (Peptone water). Two samples will be taken for each tooth. Biomechanical preparation (BMP) will be done using step-back technique up to master apical size #40 K-file. Irrigation will be done with 6 mL of the irrigants. Post-instrumentation sample (S2) will be similarly collected after irrigation as S1. It will be sent to the laboratory for processing within 2 hours. After this, teeth will be obturated using gutta-percha as a master cone and ZOE sealer. Microbiological samples (S1, S2,) will be sent to the lab Tropical Institute of Ecological Sciences(TIES)at Kottayam. Samples will be preincubated for 30 minutes and shaken vigorously in a vortex mixer for 60 seconds and will be plated on brain heart infusion agar and colonies will be counted after 24 hours using classic bacterial counting method. Both the session of treatment will be performed by the same examiner for each patient. The examiner will be aware of the material being used in every patient.
A fidelity checklist will be developed using pertinent literature and after due consideration. An observer will fill the fidelity check list to ensure objectivity and transparency.
 
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