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CTRI Number  CTRI/2023/07/055186 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Post operative pain evaluation after single sitting Root canal treatment using different files and irrigation techniques 
Scientific Title of Study   Comparative evaluation of post operative pain and radiographic changes after Single visit root canal treatment using different file systems and irrigant agitation techniques: 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 Thomas Rapheal 
Designation  Pg Student 
Affiliation  Institute Of Dental Studies and Technologies 
Address  Room No 6 Department of Conservative Dentistry and Endodontics Institute Of Dental Studies and Technologies NH 58 Kadrabad
Institute Of Dental Studies and Technologies NH 58 Kadrabad
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9740674907  
Fax    
Email  thomasjanatha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rishi Manan 
Designation  Professor and Head 
Affiliation  Institute Of Dental Studies and Technologies 
Address  Room No 6 Department of Conservative Dentistry and Endodontics Institute Of Dental Studies and Technologies NH 58 Kadrabad
Institute Of Dental Studies and Technologies NH 58 Kadrabad
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9873000350  
Fax    
Email  drmidst@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rishi Manan 
Designation  Professor and Head 
Affiliation  Institute Of Dental Studies and Technologies 
Address  Room No 6 Department of Conservative Dentistry and Endodontics Institute Of Dental Studies and Technologies NH 58 Kadrabad
Institute Of Dental Studies and Technologies NH 58 Kadrabad
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9873000350  
Fax    
Email  drmidst@gmail.com  
 
Source of Monetary or Material Support  
Room No 6 Department Of Conservative Dentistry and Endodontics Institute Of Dental Studies & Technologies,NH-58,Kadrabad  
 
Primary Sponsor  
Name  Dr Thomas Rapheal 
Address  Institute Of Dental Studies & Technologies,NH-58,Kadrabad Ghaziabad,Uttar Pradesh 
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 Thomas Rapheal  Institute of Dental Studies and Technologies,NH-58,Kadrabad,Modinagar  Room No.6,Department of Conservative Dentistry And Endodontics
Ghaziabad
UTTAR PRADESH 		 9740674907

thomasjanatha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IDST Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TruNatomy File System  TruNatomy File system (TRN, Dentsply Sirona) instruments which will be used for 1 year in this study are subjected to thermal treatment post-manufacturing. They have offcentered cross section with regressive taper, and just two cutting edges with a slim NiTi wire design, having 0.8 mm maximum flute diameter. The combination of file design and heat treatment allows for greater flexibility and efficient shaping. 
Comparator Agent  XP Endoshaper File system  The XP-endo Shaper (FKG Dentaire, La Chaux-deFonds, Switzerland) which will be used in this study for 1 year is a unique rotary instrument made with MaxWire alloy, that assumes a snake-shaped form at body temperature, adapting to root canal irregularities without removing dentine excessively.This might be beneficial to root canal preparation of teeth with minimally invasive access cavities. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Teeth with Irreversible Pulpitis, Teeth requiring Intentional Root canal treatment 
 
ExclusionCriteria 
Details  Teeth with Periapical abscess, Patients with systemic disease, Teeth requiring endodontic retreatment, Patients with swelling  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparative assessment of post operative pain after single visit root canal treatment   At 6hrs, 24hrs,
48hrs & 1 week  
 
Secondary Outcome  
Outcome  TimePoints 
Post operative radiographic assessment  After 1 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/07/2023 
Date of Study Completion (India) 01/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [thomasjanatha@gmail.com].

  6. For how long will this data be available start date provided 11-09-2023 and end date provided 30-09-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Forty patients requiring endodontic treatment in molars were randomly selected from the Department of Conservative Dentistry and Endodontics, IDST, ModiNagar for single visit root canal treatment. Teeth requiring intentional RCTs and with irreversible pulpitis were included. Teeth requiring endodontic retreatment and teeth with periapical abscess, swelling and patients with systemic diseases were excluded.
 Sample Preparation
 Pre-operative radiograph was taken for patients requiring RCT. Pre operative pain was evaluated for these patients using Visual Analogue Scale (VAS) scale.
 Access opening and working length determination were done using radiographs and apex locator under rubber dam isolation.
 Grouping of Samples
 The patients were randomly divided into two groups depending on the file system used for biomechanical preparation. Group 1 (n=20): XP Endoshaper files Group 2 (n=20): Trunatomy files.
 The patients were further subdivided into 2 sub-groups depending on the irrigant agitation techniques: Subgroup A (n=10): Sonic agitation ,Subgroup B (n=10): Ultrasonic agitation .Single cone obturation will be done .
 Pain Measurement 
Post operative pain was evaluated using Visual Analog scale (VAS scale) at 6hrs, 24hrs, 48hrs and 1 week followed by a post operative radiograph (PAI Index  was used) .Data was  recorded, tabulated and statistically analyzed. The study was successfully completed
 
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