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CTRI Number  CTRI/2025/07/090779 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing pain after root canal treatment using two different methods with and without painkillers: A Clinical Study 
Scientific Title of Study   Evaluation of post operative pain following the use of two different file systems with two different cross- sectional designs with and without the use of preoperative analgesics: A Randomized Clinical Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonia S 
Designation  PG student 
Affiliation  Tagore dental college and hospital 
Address  Room no 10, third floor, division of endodontics, department of conservative dentistry and endodontics, Tagore dental college and hospital, near Vandalur, melakkottaiyur post, Rathinamangalam, Chennai, tamilnadu, India.

Chennai
TAMIL NADU
600127
India 
Phone  7598652540  
Fax    
Email  drsonia16799@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S M Venkatesan 
Designation  professor and head of the department 
Affiliation  Tagore dental college and hospital 
Address  room no 10, third floor, division of endodontics, department of conservative dentistry and endodontics, Tagore dental college and hospital, near Vandalur, melakkottaiyur post, rathinamangalam, Chennai, Tamilnadu, India 600127

Chennai
TAMIL NADU
600127
India 
Phone  9841074234  
Fax    
Email  sriramorthodental@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sonia S 
Designation  PG student 
Affiliation  Tagore dental college and hospital 
Address  room no 10, third floor, division of endodontics, department of conservative dentistry and endodontics, Tagore dental college and hospital, near Vandalur, melakkottaiyur post, rathinamangalam, Chennai, Tamilnadu, India

Chennai
TAMIL NADU
600127
India 
Phone  7598652540  
Fax    
Email  drsonia16799@gmail.com  
 
Source of Monetary or Material Support  
Tagore dental college and hospital, near Vandalur, melakkottaiyur post, rathinamangalam,Chennai, Tamilnadu , India pincode 600127  
 
Primary Sponsor  
Name  Sonia S  
Address  66, S T Perumal street, Velayudhapuram, Aruppukottai. 626101 
Type of Sponsor  Other [Individual [ self sponsored ]] 
 
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 Sonia S  Tagore dental college and hospital  Room no 10, 3rd floor, Division of endodontics, Department of conservative dentistry and endodontics, Tagore dental college and hospital, Near Vandalur, Melakkottaiyur Post, Rathinamangalam, Tamil Nadu 600127
Chennai
TAMIL NADU 		 7598652540

drsonia16799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee, Tagore dental college and hospital  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 
Comparator Agent  not applicable  not applicable 
Intervention  Protaper gold file system, Zerodol SP  Group 1- protaper gold file system with preoperative zerodol SP given one hour before the procedure, Group 2- protaper gold file system without preoperative zerodol SP 
Intervention  VDW Rotate file system , Zerodol SP  Group 3- VDW rotate file system with preoperative zerodol SP given 1 hour before the procedure Group 4- VDW rotate file system without preoperative zerodol SP 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  single rooted teeth with symptomatic irreversible pulpits, absence of periodical changes, ASA-1 category patients, patients who have not taken anti-depressants, analgesics or sedative drugs in the past 12 hours before treatment, patient who understand visual analog scale, patient willing to provide informed consent. 
 
ExclusionCriteria 
Details  Multi rooted teeth or teeth with periapical changes, breastfeeding or pregnant women, patient allergic to anaesthetics or NSAIDS, use of immunosuppressants, patients who have taken analgesics, anti depressants or sedative drugs in the past 12 hours, calcified and resorbed canals, complex canal anatomy, non vital pulp, unrestorable teeth, teeth with acute and chronic apical abscess, teeth with previous endodontic treatment, patient with systemic infections. 
 
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 and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the intensity of postoperative pain using visual analog scale   baseline before treatment, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
monitor analgesic consumption -number & frequency postoperatively,
monitor patient comfort,
Record procedural error- file separation, canal transportation 		 6 hours, 12 hours, 18 hours, 24 hours, 48 hours & 72 hours 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 3 
Date of First Enrollment (India)   08/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This double-blind randomized clinical trial aims to evaluate postoperative pain following root canal treatment in single-rooted teeth with symptomatic irreversible pulpitis using ProTaper Gold and VDW Rotate file systems with and without preoperative analgesic Zerodol-SP. Pain levels will be assessed using a visual analog scale across multiple time intervals over 3 days. The study aims to provide insight into optimal instrumentation and preoperative medication strategies for improved patient comfort. 
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