| CTRI Number |
CTRI/2024/11/076462 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
This study checks the two different methods to measure the length of the teething its effect on curved roots |
|
Scientific Title of Study
|
Comparative Evaluation of Working Length Determination using Electronic Apex Locator and CBCT in Mesiobuccal Canal Curvatures of Maxillary First Molar - 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 Vivek Hegde |
| Designation |
Professor & H O D Department of Conservative Dentistry & Endodontics |
| Affiliation |
M.A. Rangoonwala Dental College and Hospital |
| Address |
Room No.305 Department of Conservative Dentistry and Endodontics M.A. Rangoonwala Dental College and Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune Maharashtra
Pune
MAHARASHTRA
411001
India |
| Phone |
9822055434 |
| Fax |
|
| Email |
drvivekhegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srilatha S |
| Designation |
Professor, Department of Conservative Dentistry & Endodontics |
| Affiliation |
M.A. Rangoonwala Dental College and Hospital |
| Address |
Room No. 305 Department of Conservative Dentistry and Endodontics M.A. Rangoonwala Dental College and Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune Maharashtra
Pune
MAHARASHTRA
411001
India |
| Phone |
9049397929 |
| Fax |
|
| Email |
drsri2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Salunkhe |
| Designation |
Student, Department of Conservative Dentistry & Endodontics |
| Affiliation |
M.A. Rangoonwala Dental College and Hospital |
| Address |
Room No. 305 Department of Conservative Dentistry and Endodontics M.A. Rangoonwala Dental College and Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune Maharashtra
Pune
MAHARASHTRA
411001
India |
| Phone |
8275177991 |
| Fax |
|
| Email |
saurabh961218@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Rangoonwala Dental College and Hospital Room number 305 Department of Conservative Dentistry and Endodontics Azam Campus 2390 B k b Hidayatullah Road Camp Pune |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Hegde |
| Address |
M.A. Rangoonwala Dental College and Hospital Azam Campus 2390 B K B Hidayatullah Road Camp Pune |
| Type of Sponsor |
Other [[Self]] |
|
|
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 Srilatha S |
M A Rangoonwala Dental College and Hospital |
Room number 305 Department of Conservative Dentistry and Endodontics Azam Campus 2390 B K B Hidayatullah Road Camp Pune MAHARASHTRA
Pune
MAHARASHTRA |
9049397929
drsri2005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MCE Societys M A Rangoonwala Dental College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Working Length Determination using Electronic Apex Locator in Mesiobuccal canals of Maxillary First Molar with Mild, Moderate and Severe Curvature |
The patient response is checked using VAS scale at 24hrs 48hrs and 72hrs |
| Comparator Agent |
Working Length Determination using Cone Beam Computed Tomography in Mesiobuccal canals of Maxillary First Molar with Mild,Moderate and Severe Curvature |
The patient response is checked using VAS scale at 24hrs 48hrs and 72hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients indicated for root canal treatment in permanent maxillary first molar with intact mesiobuccal surface
Periapical index score less than 3
Patients who are willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
Calcified canals
Cracks and Fractures
Resorptions and incompletely formed apices
Large Periapical Radiolucencies
Medically compromised patients
Grossly carious teeth |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The present study is conducted with the aim to evaluate and compare working length determination using an electronic apex locator and cone beam computed tomography in mesiobuccal canal curvatures of maxillary first molars |
Immediate post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare working length determination by electronic apex locator and CBCT imaging in mesiobuccal canals of maxillary first molars with mild, moderate and severe curvatures |
Immediate post operative |
|
|
Target Sample Size
|
Total Sample Size="257"
Sample Size from India="257"
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)
|
15/11/2024 |
| 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="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 current In Vivo Study is undertaken to evaluate and compare the accuracy of working length determination between cone beam computed tomography and electronic apex locator in mesiobuccal canals with mild moderate and severe curvatures in permanent maxillary first molars. This clinical study would enable clinicians to relate the significance of curvatures with working length measurements. |