| CTRI Number |
CTRI/2025/05/086487 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A CBCT-Based In Vivo Evaluation of Dentin Thickness Using ProTaper Gold, TruNatomy and TruShape |
|
Scientific Title of Study
|
Cone Beam Computed Tomography Analysis Of Remaining Dentin Thickness Using Three Different Rotary File Systems- 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 Zoya Qureshi |
| Designation |
Post graduate |
| Affiliation |
Maharishi Markandeshwar Deemed To Be University |
| Address |
Room No 6, Department of Conservative Dentistry and Endodontics, MMCDSR, Mullana, Ambala, Haryana, 133207
Ambala
HARYANA
133207
India |
| Phone |
7006578796 |
| Fax |
|
| Email |
zoyaqureshi997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surya Dahiya |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Deemed To Be University |
| Address |
Room No 6, Department of Conservative Dentistry and Endodontics, MMCDSR, Mullana, Ambala, Haryana, 133207
Ambala
HARYANA
133207
India |
| Phone |
9992221547 |
| Fax |
|
| Email |
drsuryadahiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zoya Qureshi |
| Designation |
Post graduate |
| Affiliation |
Maharishi Markandeshwar Deemed To Be University |
| Address |
Room No 6, Department of Conservative Dentistry and Endodontics, MMCDSR, Mullana, Ambala, Haryana, 133207
Ambala
HARYANA
133207
India |
| Phone |
7006578796 |
| Fax |
|
| Email |
zoyaqureshi997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar College Of Dental Sciences & Research, Mullana, Ambala, Haryana, India, 133207 |
|
|
Primary Sponsor
|
| Name |
Dr Zoya Qureshi |
| Address |
Room No 6,Department Of Conservative Dentistry and Endodontics, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana, 133207 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Zoya Qureshi |
Maharishi Markandeshwar College Of Dental Sciences and Research |
Room No 6, Department of Conservative Dentistry and Endodontics, MMCDSR, Mullana, Ambala, Haryana, 133207
Ambala
HARYANA |
07006578796
zoyaqureshi997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeshwar (Deemed To Be) University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ProTaper Gold files |
Comparative Evaluation of Remaining Dentin Thickness Using ProTaper Gold Files in one month |
| Comparator Agent |
TruNatomy Files |
Comparative Evaluation Of Remaining Dentin Thickness Using TruNatomy Files in one month |
| Comparator Agent |
TruShape Files |
Comparative Evaluation Of Remaining Dentin Thickness Using TruShape Files in one month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients between age groups of 20-55 years
2 Both men and women were included
3 Teeth with clearly visible root canals and well defined canal morphology as confirmed through periapical radiographs as well as through CBCT |
|
| ExclusionCriteria |
| Details |
1 Any systemic disease that could influence the outcome
2 Grossly decayed teeth
3 Periodontally compromised teeth
4 Rotated teeth
5 Calcified root canals
6 Presence of cysts or other periapical lesions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of three different rotary file systems on the amount of remaining dentin thickness before and after root canal instrumentation using CBCT |
Baseline and at 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/05/2025 |
| 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="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
|
The purpose of this study is to compare the amount of remaining dentin
thickness before and after root canal instrumentation using three different rotary
file systems namely: ProTaper Gold, TruNatomy and TRUShape on patients using
Cone Beam Computed Tomography. The null hypothesis is that there is no significant difference between the file systems. |