| CTRI Number |
CTRI/2025/07/090323 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Ultrasonic Tips and Masserann Kits for Removing Broken Endodontic Tools – A Clinical Study |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of ultrasonic tip versus masserann kit for the removal of separated endodontic instruments – 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 SHYAM AGRAWAL |
| Designation |
PROFESSOR |
| Affiliation |
NIMS Dental College and HOSPITAL |
| Address |
ROOM NO : 5,
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, JAIPUR, RAJASTHAN.
Jaipur
RAJASTHAN
303121
India |
| Phone |
09496748566 |
| Fax |
|
| Email |
athiraprathapan404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHYAM AGRAWAL |
| Designation |
PROFESSOR |
| Affiliation |
NIMS Dental College and HOSPITAL |
| Address |
ROOM NO : 5,
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, JAIPUR, RAJASTHAN.
Jaipur
RAJASTHAN
303121
India |
| Phone |
09496748566 |
| Fax |
|
| Email |
athiraprathapan404@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHYAM AGRAWAL |
| Designation |
PROFESSOR |
| Affiliation |
NIMS Dental College and HOSPITAL |
| Address |
ROOM NO : 5,
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,
NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, JAIPUR, RAJASTHAN.
Jaipur
RAJASTHAN
303121
India |
| Phone |
09496748566 |
| Fax |
|
| Email |
athiraprathapan404@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, NIMS DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
DR ATHIRA PRATHAPAN |
| Address |
NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY, 11-C DELHI-JAIPUR HIGHWAY,SHOBHA NAGAR, JAIPUR, RAJASTHAN, PIN CODE :303121 |
| 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 SHYAM AGRAWAL |
NIMS DENTAL COLLEGE AND HOSPITAL |
ROOM NO 5, NIMS DENTAL COLLEGE AND HOSPITAL, NIMS UNIVERSITY,
JAIPUR, RAJASTHAN
Jaipur
RAJASTHAN |
09496748566
athiraprathapan404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS UNIVERSITY RAJASTHAN, JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z181||Retained metal fragments, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Masserann Kit |
Removal of separated endodontic instruments using Masserann Kit. |
| Intervention |
Ultrasonic Tip |
Removal of separated endodontic instruments using ultrasonic tips.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presented with a broken instrument in the root canal or had an instrument separate during treatment. |
|
| ExclusionCriteria |
| Details |
Patients with serious systemic illnesses like tuberculosis, sepsis, leukemia, COPD, malaria, or those who were pregnant were excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study evaluated which file retrieval system is more efficient in terms of shorter procedure time, better dentin preservation, and reduced post-operative pain. |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Procedure time, dentin loss, immediate post-op pain |
At time of procedure, Immediate post-op
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This clinical study compares Ultrasonic tips and the Masserann kit for retrieving fractured endodontic instruments in 40 patients, aiming to determine which method offers significantly shorter retrieval times, better dentin preservation, and lower post-operative pain, thereby identifying the more effective and less invasive technique for endodontic file retrieval. |