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CTRI Number  CTRI/2025/04/084899 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the Effects of Different Natural Biotic Irrigants on Infection and Inflammation in Childrens Teeth. 
Scientific Title of Study   Comparative Evaluation of the Antimicrobial Efficacy and Periradicular Inflammatory Biomarkers of Prebiotic, Probiotic, Synbiotic and Postbiotic Irrigants in Primary Molars – A Randomized 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  Dr. Sushree Manaswinee 
Designation  Postgraduate Student 
Affiliation  Manav Rachna Dental College 
Address  Room 9 Department of Pediatric and Preventive Dentistry Manav Rachna Dental College Sector 43, Surajkund Badkhal Road, Faridabad, Haryana 121004

Faridabad
HARYANA
121004
India 
Phone  8073788286  
Fax    
Email  sushree99.sm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tanu Nangia 
Designation  Professor and Head 
Affiliation  Manav Rachna Dental College 
Address  Room 9 Department of Pediatric and Preventive Dentistry Manav Rachna Dental College Sector 43, Surajkund Badkhal Road, Faridabad Haryana 121004

Faridabad
HARYANA
121004
India 
Phone  9999384333  
Fax    
Email  tanunangia.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Tanu Nangia 
Designation  Professor and Head 
Affiliation  Manav Rachna Dental College 
Address  Room 9 Department of Pediatric and Preventive Dentistry Manav Rachna Dental College Sector 43, Surajkund Badkhal Road, Faridabad Haryana 121004

Faridabad
HARYANA
121004
India 
Phone  9999384333  
Fax    
Email  tanunangia.sds@mrei.ac.in  
 
Source of Monetary or Material Support  
Q block Basement- Room no 9 Department of Pediatric and Preventive dentistry Manav Rachna Dental College Sector 43 Faridabad Haryana 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not Applicable 
Type of Sponsor  Other [Not Applicable] 
 
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 
Sushree Manaswinee  Manav Rachna Dental College  Q block Basement Room no 9 Department of Pediatric and Preventive Dentistry Manav Rachna Dental College Sector 43 Surajkund Badkhal Road Faridabad Haryana 121004
Faridabad
HARYANA 		 8073788286

sushree99.sm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manav Rachna Institutional Ethics Committee  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 
Intervention  Postbiotic Irrigant  Postbiotic Irrigant prepared by mixing the contents of Postbiotic Capsule containing Inactivated Saccharomyces cerevisiae sp. in distilled water will be used during during biomechanical preparation of the canal 5 times for 30 seconds each 
Intervention  Prebiotic Irrigant  Prebiotic Irrigant prepared using Allium Sativum Extract diluted in distilled water will be used during during biomechanical preparation of the canal 5 times for 30 seconds each 
Intervention  Probiotic Irrigant  Probiotic Irrigant prepared by mixing the contents of 1 Satchet containing Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium longum, and Saccharomyces boulardii into Distilled water will be used during during biomechanical preparation of the canal 5 times for 30 seconds each 
Comparator Agent  Saline (Control)  Saline to be used as irrigant during biomechanical preparation of the canal 5 times for 30 seconds each 
Intervention  Synbiotic Irrigant  Synbiotic Irrigant to be used during during biomechanical preparation of the canal 5 times for 30 seconds each of Primary Molars will be a mixture of the Prebiotic Agent (Allium Sativum extract) and the Probiotic Satchet. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  a)Normal, Healthy Children between 4 to 9 years
b)Primary molars with irreversible pulpitis
c)Primary molars roots should exhibit minimal or no resorption.
d)IOPA Radiograph examination revealing primary molars with two thirds of each root remaining.
 
 
ExclusionCriteria 
Details  a)Primary molars with perforated pulpal floor and sinus tract.
b)Primary molars with intraoral & extraoral swelling.
c)Primary molars with Grade III, IV mobility.
d)Children with special healthcare needs and systemic disorders.
 
 
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 
1. To evaluate the antimicrobial efficacy of different irrigants - prebiotic, Probiotic, Synbiotic and Postbiotic Irrigants — in primary molars during pulpectomy.
2. To assess changes in the levels Periradicular inflammatory biomarkers (IL-8, IL-10) before irrigation and 72 hours after irrigation with different irrigants.
 		 1. Microbial load evaluated pre and post irrigation
2. levels of Periradicular inflammatory biomarkers to be evaluated pre and post 72 hours of irrigation 
 
Secondary Outcome  
Outcome  TimePoints 
To develop a novel biologically derived irrigant for better treatment outcome for pediatric patient.  Pre and Post Irrigation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Successful endodontic treatment relies on the complete eradication of microbial pathogens and resolution of periradicular inflammation. Persistent infections, often caused by microbial biofilms within the root canal system, are a major cause of treatment failure. Various traditionally used chemical irrigants have certain limitations which has led to increased attention towards biologically derived irrigants for their potential to provide antimicrobial efficacy while minimizing adverse effects. The increasing focus and limited scientific evidence on biologically derived irrigants specifically biotic formulations necessitates scientific evaluation of their antimicrobial efficacy. Also, there is a paucity in studies evaluating the changes in biomarker levels during pulpectomy procedures in primary teeth. Therefore it is critical to address these gaps by exploring the efficacy of biotics as irrigants and assessing the utility of periradicular biomarkers to enhance the understanding and effectiveness of pulpectomy in primary molars.

  1. The subjects will be made to sit comfortably in dental operatory room. The intra-oral examination will be done wearing a mouth mask and sterile latex gloves.
  2. A periapical radiograph will be taken in Bucco - lingual projection for proper tooth selection.
  3. Following Local Anesthesia administration using 2% Lignocaine with 1 : 80,000 Adrenaline, initial caries will be removed and endodontic access cavity preparation will be done
  4. Prior to instrumentation with any endodontic files Sample S1 will be collected using three presterilized paper points introduced consecutively into the canal to extend 2 mm beyond the apex (as measured radiographically) and left undisturbed for one minute.
  5. Then the sample will be transferred into presterilized Eppendorf tube of 2 ml PBS TM for culture. The tube will be transferred within 10 min for microbial culturing. For Periradicular biomarker analysis the sample will be collected in PBS TM and stored in the freezing unit of temperature -80 C until ELISA test is done.
  6. Working length will be then determined using an electronic apex locator and confirmed radiographically.
  7. The root canals will be cleaned and shaped using #10, #15 files followed by pediatric hand or rotary files.
  8. Each patient will be randomly allotted by lottery method to one of the five groups for Irrigation :
    Group 1 : Control (Saline)
    Group 2 : Prebiotic irrigant 
    Group 3 : Probiotic irrigant 
    Group 4 : Synbiotic irrigant 
    Group 5 : Postbiotic irrigant 
  9. Copious irrigation of the root canal will be followed by sample collection S2
  10. Post Irrigation, canals will be dried and closed cotton dressing with temporary restoration will be given and the patient will be recalled after 72 hours.
  11. After 72 hours, Temporary Restoration will be removed and Sample collection S3 will be done
  12. Canals will be dried with absorbent paper point and followed by obturation with Metapex (Calcium hydroxide with iodoform paste). Final Restoration using Glass Ionomer Cement will be done.
  13. The samples S1 & S2 will be tested for Colony forming Units on Blood Agar Plates.
  14. The samples S1 & S3 will be tested using ELISA kit for levels of IL8 and IL10.

 
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