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CTRI Number  CTRI/2020/02/023339 [Registered on: 14/02/2020] Trial Registered Prospectively
Last Modified On: 13/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain intensity after the utilisation of different file systems in single visit endodonticsl. 
Scientific Title of Study   Comparison of post operative pain intensity after the utilisation of conventional rotary file in comparison with two anatomic instrumentation systems in single visit endodontics: A randomised clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuj Bhardwaj 
Designation  Professor 
Affiliation  College of Dental Science and Hospital 
Address  Conservative Dentistry & Endodontics, Room No.9, F-12,Jhoomer Ghat, near Mashal Hotel, Rau, Indore, M.P.

Indore
MADHYA PRADESH
453331
India 
Phone  7898540222  
Fax    
Email  dranuj_84@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anuj Bhardwaj 
Designation  Professor 
Affiliation  College of Dental Science and Hospital 
Address  Conservative Dentistry & Endodontics, Room No. 9 , F-12,Jhoomer Ghat, near Mashal Hotel, Rau, Indore, M.P.

Indore
MADHYA PRADESH
453331
India 
Phone  7898540222  
Fax    
Email  dranuj_84@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Anuj Bhardwaj 
Designation  Professor 
Affiliation  College of Dental Science and Hospital 
Address  Conservative Dentistry & Endodontics, Room No. 9 , F-12,Jhoomer Ghat, near Mashal Hotel, Rau, Indore, M.P.

Indore
MADHYA PRADESH
453331
India 
Phone  7898540222  
Fax    
Email  dranuj_84@yahoo.co.in  
 
Source of Monetary or Material Support  
College of Dental Science and Hospital, Rau, Indore-453331, Madhya pradesh, India. 
 
Primary Sponsor  
Name  Dr Anuj bhardwaj 
Address  F-12, Jhoomer Ghat, Rau, Indore-453331, Madhya Pradesh 
Type of Sponsor  Other [Principal Investigator] 
 
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 Anuj Bhardwaj  College of Dental Science and Hospital  Dept of Conservative Dentistry & Endodontics, Room No9, F-12, Jhoomer ghat, near Mashal hotel, Rau, indore-453331.
Indore
MADHYA PRADESH 		 7898540222

dranuj_84@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of College of Dental Science and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Irreversible pulpitis without periapical pathosis in maxillary and mandibular molars  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endodontic instrument systems (files)  One rotary file and two anatomic instrumentation systems will be used in cases of irreversible pulpitis without periapical pathosis for comparison of postoperative pain after single visit endodontics  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Maxillary and mandibular first and second molars, teeth with irreversible pulpitis with/without apical periodontitis with no periapical lesion, teeth with fully formed roots, teeth with non-calcified canals
 
 
ExclusionCriteria 
Details  Root canal treated teeth requiring retreatment, cases of swelling with acute pain, non-vital teeth, teeth with root resorption, immature/open apices, pathologic mobility, complex anatomy, root caries, gross decay, teeth indicated for intentional root canal treatment, pregnant patients, medically compromised patients, patients using analgesics or nonsteroidal or steroidal anti-inflammatory drugs within 12 hours
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain  Six hours, 24 hours, 48 hours and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of analgesic intake  Any point of time between the termination of the treatment and 72 hours after the completion of the treatment 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   14/02/2020 
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="1"
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  
Single-visit endodontics is associated with numerous complications and postoperative pain is one of them. One of the most common factors influencing the occurrence of postoperative pain is the apical extrusion of debris during instrumentation. The instrumentation technique, as well as the design, type, and size of the instrument, have a major influence on the incidence of postoperative discomfort. In the literature search, there is a lack of clinical evidence comparing the postoperative pain after using different nickel-titanium systems such as ProTaper Next (PTN), Self-Adjusting File (SAF), and XP-endo Shaper (XPS) which employ varied file design and motion kinematics. The null hypothesis tested was that there is no difference in the postoperative pain following the use of PTN, SAF, and XPS instrumentation systems. The aim of the study was, therefore, to compare the post-instrumentation pain following the use of PTN, SAF, and XPS.
 
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