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CTRI Number  CTRI/2019/07/019960 [Registered on: 01/07/2019] Trial Registered Prospectively
Last Modified On: 26/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain evaluation with three different methods of working length taken 
Scientific Title of Study   Effect of three different methods of working length determination during root canal preparation on post operative pain - An in vivo study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Boris Saha 
Designation  Post Graduate 
Affiliation  Dr Z.Ahmad dental college and hospital 
Address  Department of conservative dentistry. Dr ziauddin ahmed dental college. AMU , Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  09804427359  
Fax    
Email  borissaha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Surendra kumar Mishra 
Designation  Professor 
Affiliation  Dr Z.Ahmad dental college and hospital 
Address  Dr ziauddin ahmed dental college AMU , aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  09804427359  
Fax    
Email  drsurendrakmishra69@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Boris Saha 
Designation  Post Graduate 
Affiliation  Dr Ziauddin ahmed dental college and hospital 
Address  Department of conservative dentistry and endodontics Dr Ziauddin ahmed dental college AMU , Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  09804427359  
Fax    
Email  borissaha@gmail.com  
 
Source of Monetary or Material Support  
Department of conservative dentistry and endodontics Dr Ziauddin ahmed dental college and hospital AMU , Aligarh 
 
Primary Sponsor  
Name  Department of conservative dentistry and endodontics  
Address  Dr Z. A dental college aligarh muslim university aligarh 
Type of Sponsor  Government medical college 
 
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 Boris Saha  Dr Ziauddin Ahmed dental college and hospital  Department of conservative dentistry and endodontics
Aligarh
UTTAR PRADESH 
09804427359

borissaha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional of ethics committee , facaulty of medicine , amu aligarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Electronic Apex Locator  Endodontic treatment will be done , working length will be measured by using electronic apex locator 
Intervention  Electronic Apex Locator with simultaneous root canal preparation  Endodontic treatment will be done with endomotor which has inbuilt apex locator , therefore root canal preparartion will be done with simultaneous working length determination 
Comparator Agent  Radiographic method of working length determination  Endodontic treatment will be done with working length determination using radiographic method 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Acute pain in single rooted tooth  
 
ExclusionCriteria 
Details  Patient with systemic disease ,sinus tract , periapical lesion ,swelling and sinus tract , bruxism , severely damaged tooth and severe periodontal disease 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain   pain evaluation at 24 hours, 48 hours and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Patients will be evaluated for need of post operative analgesics  24 Hours
48 Hours
72 Hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2019 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The aim of the present study will be to clinically evaluate the post operative pain during root canal preparation , with three different methods of working length preparation. 

Suitable number of patients will be selected for this in-vivo study . Single rooted tooth will be taken into consideration for this study . Healthy young patients having irrerversible pulpitis with  tooth positive to a percussion test , negative to palpation test  and without any periapical lesion or any systemic disease will be included in this study

Patients which will be excluded from the study according to the following criteria: those with systemic diseases, swelling, sinus tract, or preoperative palpation pain , those having bruxism or clenching , a severely damaged tooth, severe periodontal disease in related tooth or resorption in related tooth , having previously undergone root canal treatment in related tooth.

A digital radiograph will be used to confirm the presence of single root for the tooth to be operated on . Preoperative pulpal diagnosis will be performed by both cold test and Electric pulp test .Periapical diagnosis will be performed by periapical radiographs and percussion and palpation tests  .

Patients will be randomly distributed into 3 experimental groups viz. Radiographic group, Electronic apex locator group and Simultaneous Prepared Group; with equal number of  patients  in each group. After the root canal preparations , patient will be evaluated for post operative pain after 24hrs ,48 hrs & 72 hrs respectively , keeping in mind no anaelgesics were given post-operatively before pain evaluation . Patient will respond for pain after percussion on a designed visual analogue scale for pain. 

 
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