| CTRI Number |
CTRI/2025/03/083403 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is done to evaluate the surface topographic changes in single system pediatric rotary files after repeated use using optic profilometer.
|
|
Scientific Title of Study
|
Evaluation of Surface Topographic Changes In Single System Pediatric Rotary Files Following Repeated Use - 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 |
Dr Vignesh Ravindran |
| Designation |
Reader |
| Affiliation |
saveetha dental college and hospital |
| Address |
Clinic 28, Department of Pediatric and preventive dentistry, Saveetha dental college and hospital,
No.162, Poonamallee high road,
vellapancahavadi,
Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9789934476 |
| Fax |
|
| Email |
vigneshr.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhuvaneswari Natarajan |
| Designation |
Postgraduate student |
| Affiliation |
saveetha dental college and hospital |
| Address |
clinic 28, department of pediatric and preventive dentistry,Saveetha dental college and hospital,
No.162, Poonamallee high road,
vellapancahavadi,
Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8220069215 |
| Fax |
|
| Email |
bhuvanaraj97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vignesh Ravindran |
| Designation |
Reader |
| Affiliation |
saveetha dental college and hospital |
| Address |
Clinic 28, Department of paediatric and preventive dentistry, Saveetha dental college and hospital,
No.162, Poonamallee high road,
vellapancahavadi,
Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9789934476 |
| Fax |
|
| Email |
vigneshr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bhuvaneswari Natarajan |
| Address |
Saveetha dental college and hospitals,
No.162, Poonamallee high road
vellapanchavadi
Chennai |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vignesh Ravindran |
Saveetha dental college and hospitals,
No.162, Poonamallee high road
vellapanchavadi
Chennai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR VIGNESH R |
Saveetha dental college and hospitals |
Clinic 28,Department of pediatric and preventive dentistry,Saveetha dental college and hospital,
No.162, Poonamallee high road,
vellapancahavadi,
Chennai
TAMIL NADU |
9789934476
vigneshr.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAVEETHA DENTAL COLLEGE AND HOSPITALS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CHRONIC IRREVERSIBLE PULPITIS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kedo Nano plus |
topographic changes and cutting edge efficiency will be assessed at baseline,1st use,3rd use,6th use,9th use,12th use, and 15th use. one tooth will be counted as one use. |
| Intervention |
Kedo S Plus |
topographic changes and cutting edge efficiency will be assessed at baseline,1st use,3rd use,6th use,9th use,12th use, and 15th use. one tooth will be counted as one use. |
| Intervention |
Kedo S square |
topographic changes and cutting edge efficiency will be assessed at baseline,1st use,3rd use,6th use,9th use,12th use, and 15th use. one tooth will be counted as one use. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Teeth indicative of pulpectomy and primary molars with only three roots |
|
| ExclusionCriteria |
| Details |
Primary anterior teeth and primary molars with more than three roots. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surface topographic changes |
at baseline,3rd use,5th use,9th use,12th use and 15th use of the file. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cutting efficiency of the file |
At baseline,3rd use,5th use,9th use,12th use & 15th use of the file. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/03/2025 |
| 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="0"
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
|
This study aims to assess the surface topographic changes in single-system pediatric rotary files after multiple uses in primary teeth using stereomicroscope. A randomized clinical trial will be conducted on extracted primary teeth requiring pulpectomy. Pediatric rotary files will be used for root canal preparation and categorized based on the number of uses (e.g., new, after 3 uses, after 5 uses). Surface characteristics will be evaluated using stereomicroscope to detect wear, deformation, or micro-fractures. Data will be statistically analyzed to determine the impact of repeated use on file integrity. The study aims to provide insights into the safe usage limits of pediatric rotary files, ensuring effective and safe endodontic treatment in children while minimizing instrument failure risks. Findings will guide clinicians on the longevity and safety of pediatric rotary files, optimizing their clinical application and enhancing patient safety.
|