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CTRI Number  CTRI/2023/09/057727 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 07/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A Clinical Study on Quantitative Analysis of Antibacterial Efficacy of Herbal Irrigants Against Endodontic Microflora  
Scientific Title of Study   Quantitative Analysis of Antibacterial Efficacy of Herbal Irrigants Against Endodontic Microflora – A Clinical Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lovely Das 
Designation  MDS Post Graduate Trainee 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  EF-10, 1620 Rajdanga Main Road, East Kolkata Township
157/F, Nilgunj Road, Sahid Colony, Panihati, Sodepur, Kolkata- 700114 Department of Conservative Dentistry and Endodontics (post graduate division)
Kolkata
WEST BENGAL
700107
India 
Phone  08274863635  
Fax    
Email  drlovelydas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ipsita Maity 
Designation  Professor 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  Vivekananda Abasan, 94/25 Nayapatti Road, Shyamnagar, Kolkata
157/F, Nilgunj Road, Panihati, Kolkata-700114 Department of Conservative Dentistry and Endodontics
Kolkata
WEST BENGAL
700055
India 
Phone  09051860156  
Fax    
Email  ipsita.maity@gnidsr.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Lovely Das 
Designation  MDS Post Graduate Trainee 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  EF-10, 1620 Rajdanga Main Road, P.S- Kasba, Kolkata-700107
157/F, Nilgunj Road, Panihati, Kolkata-700114 Department of Conservative Dentistry and Endodontics (post graduate division)
Kolkata
WEST BENGAL
700107
India 
Phone  09007162723  
Fax    
Email  drlovelydas@gmail.com  
 
Source of Monetary or Material Support  
Guru Nanak Institute of Dental Sciences and Research 
Lovely Das 
 
Primary Sponsor  
Name  Lovely Das  
Address  EF-10. 1620 Rajdanga Main Road, Kolkata - 700107 
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 Lovely Das   Guru Nanak IInstitute of Dental Sciences and Research  157/F, Nilgunj Road, Sahid Colony, Panihati, Kolkata- 700114 Department of Conservative Dentistry and Endodontics (post graduate division)
Kolkata
WEST BENGAL 
08274863635

drlovelydas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3% Sodium Hypochlorite   used as 5 ml solution after every instrumentation with sided vented needle during root canal treatment 
Intervention  Alcoholic Neem Extract irrigating solution  Alcoholic Neem Extract root canal irrigant used as 5 ml solution after every instrumentation with sided vented needle during root canal treatment 
Intervention  Green tea 3.5% root canal irrigating solution  Green tea 3.5% root canal irrigant used as 5 ml solution after every instrumentation with sided vented needle during root canal treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Pulpal necrosis tooth with Symptomatic apical periodontits or Asymptomatic apical periodontitis in Single / multirooted tooth ( in case of multirooted tooth the largest canal for posterior teeth)
 
 
ExclusionCriteria 
Details  Wide/open apex
Re – treatment endodontic cases
Acute apical abscess
Periodontal disease (presence of pocket >4 mm)
Pregnant patient
Medically compromised patients
Calcified canal
Internal resorption cases
Patient who is on antibiotic medications for the last 3 months
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of Neem solution against micro-organisms present in root canal.
2. To evaluate the efficacy of Green tea solution against micro-organisms present in root canal. 
Before & after using the designated solution 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate & compare the antimicrobial efficacy of Neem and Green tea solution.
2. To evaluate and compare the antimicrobial efficacy of Neem and Green tea solution with the Sodium hypochlorite.
 
Before & after using the designated solution in a span of 6 months to 1 year sample collection 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/09/2023 
Date of Study Completion (India) 10/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drlovelydas@gmail.com].

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 01-09-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The main objectives of the non-surgical endodontic treatment are the elimination of micro-organisms from the root canal space and the prevention of reinfection. Chemomechamical preparation is considered to be one of the most important steps in the management of infected root canal system which includes proper instrumentation and meticulous irrigation. Ideally, an endodontic irrigant should have antimicrobial efficacy, tissue dissolving capacity along with nontoxic and biocompatible nature. Through the years, various irrigating solutions have been used in contemporary dentistry, however none of them has all the properties needed. So, a combined use of separate irrigants is recommended to ensure the successful outcome, which makes the procedure quite lengthy. Sodium hypochlorite (NaOCl), is a reducing agent, straw colored solution used majorly as the main root canal irrigant and responsible for antimicrobial action. On the basis of published data, a wide range of percentage of sodium hypochlorite can be used from 0.5% - 5.2%. nevertheless, it has some serious complications, some of which are life-threatening. It causes chemical burn on extrusion to the periapical area during root canal treatment. In higher concentration it causes hemolysis, ulceration, inhibition of neutrophil migration, damage to fibroblast cells, and necrosis on extrusion to surrounding tissue. Herbal irrigants are comparatively newer irrigant in the field of endodontics, focus on the owning of their advantages and minimal side effects.  Neem and green tea are full of different flavonoids, catechins which antimicrobial and beneficial in various ways. Therefore, the aim of this study is to evaluate and compare the antimicrobial efficacy of these two herbal irrigants with most commonly used irrigant, sodium hypochlorite.

 
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