| CTRI Number |
CTRI/2025/07/091867 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Irrigation Methods Used in Root Canal Treatment of Baby Teeth |
|
Scientific Title of Study
|
Comparative evaluation of the effect of Ultrasonic irrigation and modified conventional syringe irrigation using hydrogen peroxide in single visit pulpectomy A Randomized clinical 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 |
Govinda Rajaa V K |
| Designation |
Postgraduate |
| Affiliation |
Priyadarshini Dental college and Hospital |
| Address |
Room No 6. Department of pediatric and preventive dentistry. Priyadarshini dental college and hospital, No 1VGR gardens, Pandur,
Tiruvallur
VGR gardens, Pandur, Tiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9444905025 |
| Fax |
|
| Email |
govindarajaa8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Veerakumar R |
| Designation |
Professor and Head |
| Affiliation |
Priyadarshini Dental college and Hospital |
| Address |
Room No 6. Department of pediatric and preventive dentistry. Priyadarshini dental college and hospital, No 1VGR gardens, Pandur,
Tiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9843290444 |
| Fax |
|
| Email |
thilothamasathiya772@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Govinda Rajaa V K |
| Designation |
Postgraduate |
| Affiliation |
Priyadarshini Dental college and Hospital |
| Address |
Room No 6. Department of pediatric and preventive dentistry. Priyadarshini dental college and hospital, No 1VGR gardens, Pandur,
Tiruvallur
Thiruvallur
TAMIL NADU
631203
India |
| Phone |
9444905025 |
| Fax |
|
| Email |
govindarajaa8@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GOVINDARAJAA V K |
| Address |
1 V G R Gardens, V G R Nagar, Pandur, Thiruvallur District, Tiruvallur, Tamil Nadu 631203 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 Govinda Rajaa V K |
Priyadharshini Dental College and Hospital |
Room No 6. Department of pediatric and preventive dentistry. Priyadarshini dental college and hospital, No 1VGR gardens, Pandur,
Tiruvallur
Thiruvallur
TAMIL NADU |
9444905025
govindarajaa8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE - PDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified conventional syringe irrigation |
Modified conventional syringe irrigation while doing pulpectomy and follow up for 14 days. |
| Intervention |
Ultrasonic Irrigation |
Ultrasonic Irrigation and follow up for 14 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Deciduous molars that require pulpectomy procedures.
2. Deciduous molar with more than 2/3rd of root.
|
|
| ExclusionCriteria |
| Details |
1. Patient with Systemic Disorders.
2. Patient who does not give consent to the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonic irrigation outcome |
Outcome will be assessed at intervals of 1 3 7 14 days intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified conventional syringe irrigation |
Outcome will be assessed at intervals of 1 3 7 14 days intervals |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/06/2026 |
| 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="3"
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
|
The present study is to evaluate and compare the effect of Ultrasonic irrigation and modified conventional syringe irrigation using hydrogen peroxide in single visit pulpectomy procedure in primary molars. To assess the effect of two irrigation systems in reducing the post-operative pain following pulpectomy procedure. 2 |