| CTRI Number |
CTRI/2024/06/068954 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to compare the amount of dentin removed by different file systems used during root canal treatment in human molar teeth |
|
Scientific Title of Study
|
Effect of Rotary and Reciprocating Motion on the Dentin Thickness at the Danger Zone of Mandibular Molars using Cone Beam Computed Tomography: An Observational 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 |
Ipsita Mangla |
| Designation |
MDS 1st year |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
Room number- 124, Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, B.I.U Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
07983441389 |
| Fax |
|
| Email |
ipshita.mangla1100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar Hans |
| Designation |
Professor and Head, Clinical Department |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
Room number - 124, Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9829779528 |
| Fax |
|
| Email |
hansie51@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Kumar Hans |
| Designation |
Professor and Head, Clinical Deapartment |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
Room number-124, Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, B.I.U Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9829779528 |
| Fax |
|
| Email |
hansie51@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Sciences, Bareilly- 243006 , Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences Bareilly |
| Address |
Institute of Dental Sciences, Bareilly- 243006 , Uttar Pradesh, India |
| Type of Sponsor |
Other [Private Dental 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 Ipsita Mangla |
Institute of Dental Sciences, Bareilly |
Room Number - 124, Department of Conservative Dentistry and Endodontics, Bareilly
Bareilly
UTTAR PRADESH |
05812526244
ipshita.mangla1100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, I.D.S, Bareilly, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, (2) ICD-10 Condition: Z049||Encounter for examination and observation for unspecified reason, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reciprocating file systems |
Reciprocating file systems which utilize clockwise and counterclockwise motion for root canal preparation, Total Duration- 1 Year |
| Comparator Agent |
Rotary File Systems |
Rotary file system which utilize continuous rotational motion for root canal preparation, Total Duration- 1 Year |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Extracted Permanent Mandibular Molar with Intact Root Structure
2. Teeth with Closed Apex |
|
| ExclusionCriteria |
| Details |
1. Permanent mandibular molars with incompletely formed apex
2. Permanent mandibular molars with obliterated root canals
3. Permanent mandibular molars with root resorption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of amount of dentin removed with different rotary and reciprocating file systems |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the amount of dentin removed with different rotary & reciprocating file systems |
Six Months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ipshita.mangla1100@gmail.com].
- For how long will this data be available start date provided 09-11-2025 and end date provided 09-11-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
There is a scarcity of research comparing the influence of various: Rotary & Reciprocating file systems having the same taper and tip diameter on dentin thickness values in the specified danger-zone (DZ) of mandibular molars. Therefore, the objective of this study will be to evaluate the influence of different Rotary and Reciprocating file systems on dentin thickness values in the ‘Danger-zone’ of mandibular molars through the use of CBCT imaging.
|