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CTRI Number  CTRI/2025/07/090003 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Magnet-treated water and Salt Water for Reducing Bacteria in Milk Teeth 
Scientific Title of Study   Comparative Evaluation of the Antimicrobial Efficacy of Magnetized Water and Normal Saline against E. faecalis in Primary Teeth: An in vivo 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  Dr Ashray Nimje 
Designation  Post Graduate Student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Room no. 302, Department of Pediatric and Preventive Dentistry, 3rd floor, Sharad Pawar Dental College and Hospital, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  7506180064  
Fax    
Email  ashraynimje@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nilima Thosar 
Designation  Professor and Head of Department  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Room no. 302, Department of Pediatric and Preventive Dentistry, 3rd floor, Sharad Pawar Dental College and Hospital, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9284522620  
Fax    
Email  drnthosar@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nilima Thosar 
Designation  Professor and Head of Department  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Room no. 302, Department of Pediatric and Preventive Dentistry, 3rd floor, Sharad Pawar Dental College and Hospital, Sawangi Meghe


MAHARASHTRA
442001
India 
Phone  9284522620  
Fax    
Email  drnthosar@rediffmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institue of Higher Education and Research, Sawangi Meghe, Wardha, India-442001 
 
Primary Sponsor  
Name  Datta Meghe Institue of Higher Education and Research 
Address  Sawangi Meghe, Wardha, India-442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashray Nimje  Sharad Pawar Dental College  Room no. 302, Department of Pediatric and Preventive Dentistry, 3rd Floor, Sharad Pawar Dental College and Hospital, Sawangi Meghe
Wardha
MAHARASHTRA 
7506180064

ashraynimje@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Committee, Datta Meghe Institute of Higher Education and Research  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Magnetized Water  Magnetized water is an alkaline water with pH 10 which is made by placing distilled water between 2 magnets  
Comparator Agent  Normal Saline  Distilled water containing sodium chloride forms the normal saline. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Primary teeth with deep carious lesions indicated for pulpectomy.
2. Teeth with necrotic pulp.
 
 
ExclusionCriteria 
Details  1. Children with systemic diseases or immunocompromised conditions.
2. Teeth with severe destruction not suitable for restoration.
3. Permanent teeth.
4. Primary teeth with periapical abscess
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Magnetized water will have better efficacy against E. faecalis  Assessment will be done before starting the procedure and after completion of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   25/07/2025 
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="1"
Months="0"
Days="0" 
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  

Microorganisms play a crucial role in the development of pulpal and periapical infections, with Enterococcus faecalis (E. faecalis) being one of the most persistent pathogens found in root canal failures. Effective elimination of such microorganisms is essential for the success of endodontic therapy. Magnetized water, with its altered physicochemical properties, has recently emerged as a potential alternative root canal irrigant due to its increased alkalinity and reduced surface tension. This study aims to compare and evaluate the antimicrobial efficacy of magnetized water and normal saline against E. faecalis in primary teeth through an in vivo study. This will be in vivo study conducted on primary teeth indicated for pulpectomy in children. Pre- and post-irrigation microbial samples were collected from selected teeth and cultured on Brain Heart Infusion (BHI) agar to determine colony-forming units (CFUs) of E. faecalis. The teeth were randomly assigned to two groups: Group A (irrigated with magnetized water) and Group B (irrigated with normal saline). The reduction in microbial load was recorded and compared between the two groups.

 
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