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CTRI Number  CTRI/2024/09/073304 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the differences between two cavity designs - incisal-shifted access and traditional lingual access using CBCT. 
Scientific Title of Study   Comparison of angle of curvature between incisal-shifted access and traditional lingual access for mandibular anterior teeth using CBCT - 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 and HOD Department of Conservative Dentistry and 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 KB Hidayatullah Road Camp Pune Maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  9822055434  
Fax    
Email  drvivekhegde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saleel Kurane 
Designation  PG Student 
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 KB Hidayatullah Road Camp Pune Maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  7709885343  
Fax    
Email  saleelkuranesk302@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saleel Kurane 
Designation  PG Student 
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 KB Hidayatullah Road Camp Pune Maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  7709885343  
Fax    
Email  saleelkuranesk302@gmail.com  
 
Source of Monetary or Material Support  
M A Rangoonwala Dental College and Hospital Room No 305 Department of Conservative Dentistry and Endodontics Azam Campus 2390 KB Hidayatullah Road Camp Pune Maharashtra 
 
Primary Sponsor  
Name  Dr Vivek Hegde 
Address  M A Rangoonwala Dental College and Hospital Azam Campus 2390 KB Hidayatullah Road Camp Pune  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vivek Hegde  M A Rangoonwala Dental College and Hospital  Room No 305 Department of Conservative Dentistry and Endodontics Azam Campus 2390 KB Hidayatullah Road Camp Pune Maharashtra
Pune
MAHARASHTRA 		 9822055434

drvivekhegde@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Incisal shifted access  Preoperative CBCT will be taken. Incisal shifted access cavity preparation will be done. Immediate postoperative CBCT after access cavity preparation will be taken. Both these CBCTs will be compared. The patient will be recalled after 7 days, 15 days and one month to evaluate the treatment outcome. 
Comparator Agent  Traditional lingual access  Preoperative CBCT will be taken. Traditional lingual access cavity preparation will be done. Immediate postoperative CBCT after access cavity preparation will be taken. Both these CBCTs will be compared. The patient will be recalled after 7 days, 15 days and one month to evaluate the treatment outcome. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Teeth with irreversible pulpitis.
mandibular anterior teeth with single root, single canal confirmed using pre-operative CBCT scan. 
 
ExclusionCriteria 
Details  Attrited teeth, grossly carious teeth.
Teeth having anatomical variations (dilacerated roots, fused roots, gemination).
Teeth with physiologic or pathologic root resorption.
Calcified teeth.
Teeth having mobility or lack of adequate bone support. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the difference between angle of curvature in incisal-shifted access and traditional lingual access.  Preoperative CBCT will be taken before access cavity preparation and postoperative CBCT will be taken after 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the centering ability between incisal-shifted access & traditional lingual access.
To clinically evaluate for pain tenderness on percussion sinus tract etc.  		 After 7 days 15 days & one month. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   16/09/2024 
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   Creating an appropriate access cavity is crucial for successful root canal treatment. While preparing access cavities in anterior teeth, the standard approach has been employed to create a triangular outline on the center of the lingual surface. However, this traditional lingual access (TLA) cavity preparation often results in the access cavity direction differing from the direction of the root canal, particularly in the apical third. This is because the long axis of the tooth’s crown often differs from the long axis of the root canal, creating a discrepancy that makes it challenging to align the access cavity perfectly with the canal. Hence in this study, the incisal shifted access is evaluated. 
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