| 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
|
|
|
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
|
|
|
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.
|