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CTRI Number  CTRI/2025/07/091575 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARATIVE EVALUATION OF CONVENTIONAL SYSTEM AND IONTOPHORESIS INFUSED IRRIGATING SYSTEM FOR PULPECTOMY IN PRIMARY MOLARS 
Scientific Title of Study   COMPARATIVE EVALUATION OF CONVENTIONAL SYSTEM VS IONTOPHORESIS INFUSED IRRIGATING SYSTEM FOR PULPECTOMY IN PRIMARY TEETH - RCT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rehan Ahmed Modi 
Designation  Post Graduate 
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta,
Riyaz Manzil , opp Madina Apparatment, Langawada Street , Junagadh, Gujarat, 362001
Junagadh
GUJARAT
384351
India 
Phone  9104142777  
Fax    
Email  rehanmodi3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shoba Fernandes 
Designation  Professor and Head of Department 
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  Dept no 8 , Narsinhbhai Patel Dental College and Hospital,S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta,

Mahesana
GUJARAT
384351
India 
Phone  7567622346  
Fax    
Email  vshobaf@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rehan Ahmed Modi 
Designation  Post Graduate 
Affiliation  Narsinhbhai Patel Dental College and Hospital 
Address  S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta,
Riyaz Manzil , opp Madina Apparatment, Langawada Street , Junagadh, Gujarat, 362001

GUJARAT
384351
India 
Phone  9104142777  
Fax    
Email  rehanmodi3@gmail.com  
 
Source of Monetary or Material Support  
Narsinhbhai Patel Dental College and Hospital,Visnagar,Gujarat, India - 384315 
 
Primary Sponsor  
Name  Rehan Modi 
Address  Riyaz Manzil, Opp Madina appartment, Langawada street , Junagadh Gujarat , India - 362001 
Type of Sponsor  Other [By Own] 
 
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 
Rehan Ahmed Modi  Narsinhbhai Patel Dental College and Hospital  S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta,
Mahesana
GUJARAT 		 09104142777

rehanmodi3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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  Conventional irrigation  Normal irrigation with syringe will be done in root canal of primary molars till the treatment is being completed 
Comparator Agent  Iontophoresis Irrigating Device  It will be used to irrigate the root canal of primary molars. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Patient age between 5-9 years
Patients requiring bilateral Pulpectomy in mandibular molars.
Teeth with intact roots or more than 2/3rd of root present.
Patient who exhibits cooperative behaviour (Frankl Behaviour scale). 
 
ExclusionCriteria 
Details  Children with special health care conditions.
Children who have taken antibiotic medication.
Teeth with excessive root resorption and mobility.
Patients who exhibit definitive negative behaviour.
Presence of dental abscess. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To establish the microbiota in the root canal of primary teeth.
To establish the anti-microbial efficacy of iontophoresis as irrigating system in reducing the microbial count of the primary teeth root canals using culture
tests. 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/06/2026 
Date of Study Completion (India) 14/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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 - NO
Brief Summary   A RCT will be conducted among 5-9 years of age in which there will be comparison done between conventional irrigating system and Iontophoresis infused irrigating system for dental procedures
Study will be done in 3 phases PHASE I Probe Design PHASE II Pilot Study PHASE III In-Vivo. Patients requiring bilateral Pulpectomy in mandibular molars, teeth with intact roots or more than 2/3rd of root present, patient who exhibits cooperative behaviour (Frankl Behaviour scale) will be included for the study and Children with special health care conditions, children who have taken antibiotic medication, teeth with excessive root resorption and mobility, patients who exhibit definitive negative behaviour, presence of dental abscess will be excluded
This study will be performed in patients visiting Department of Pediatric and
Preventive Dentistry, NPDCH, SPU Visnagar. 30 children will be included in the
study according to selection criteria.
2. Ethical clearance for carrying out the study will be obtained prior from the
Institutional Ethics committee (IEC) before starting study. Study will be carried out
after written informed consent from each patient and parents.
3. After clinical, Radiographic examination and based on inclusion criteria, patients
requiring bilateral pulpectomy will be selected.
4. First irrigation system to be used will be decided by chit-pick method.
5. After patient selection, LA administration and rubber dam isolation will be done.
6. Caries excavation and access opening will be done conventionally using airoter and
burs.
7. Pulp tissue will be extirpated.
8. Canals will be irrigated by Normal Saline
9. Irrigation will be done with Iontophoresis and Conventional needle
10. 1st sample (S1) will be collected from the canal with sterile paper points inserted up
to Working Length for 1 minute. For sample selection, distal canals will be selected
for Primary Mandibular molars. Multiple samples will be collected for culture test.
11. Biomechanical preparation will be done by using one larger sequence files, up to
No-35 K-file: 2% taper (MANI, INC, JAPAN) in step back manner in the same visit
using randomized irrigation system.
12. 2nd sample (S2) will be collected post instrumentation with same method.
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Candidate Signature Guide Signature
13. Samples (S1 and S2) will be put in Nutrient Broth and sent to laboratory for cultural
analysis to count the growth of bacterial isolates. The Colony-Forming Unit (CFU)
counts from the pre-disinfection sample (S1) will serve as a baseline for comparing the
reduction in the CFU count post-irrigation (S2).
14. Obturation will be done with Endoflas followed by crown.
 
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