FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055270 [Registered on: 17/07/2023] Trial Registered Prospectively
Last Modified On: 14/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of pain in single visit root canal treatment of lower back teeth by using two different root canal cleaning techniques after 4, 24 and 48 hours. 
Scientific Title of Study   Post operative pain assessment in single visit endodontics of mandibular first and second molars by using two different irrigation techniques after 4, 24 and 48 hours – double blinded 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  Sreelakshmi P C 
Designation  Junior resident  
Affiliation  GOVT DENTAL COLLEGE KOTTAYAM 
Address  Department of conservative dentistry and endodontics Room no - 404 Govt Dental College Gandhinagar P O Kottayam

Kottayam
KERALA
686008
India 
Phone  9496694158  
Fax    
Email  pcsreelakshmi95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shoba K 
Designation  Head of the Department 
Affiliation  GOVT DENTAL COLLEGE KOTTAYAM 
Address  Department of Conservative Dentistry and Endodontics Govt Dental College Gandhinagar P O Kottayam

Kottayam
KERALA
686008
India 
Phone  9496694158  
Fax    
Email  drshobak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sreelakshmi P C 
Designation  Junior resident  
Affiliation  Govt Dental College Kottayam 
Address  Department of Conservative Dentistry and Endodontics Room no - 404 Govt Dental College Kottayam

Kottayam
KERALA
686008
India 
Phone  9496694158  
Fax    
Email  pcsreelakshmi95@gmail.com  
 
Source of Monetary or Material Support  
Govt Dental College Kottayam Gandhinagar PO Kottayam Kerala 
 
Primary Sponsor  
Name  Sreelakshmi P c 
Address  Govt Dental College Kottayam 
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 Sreelakshmi P C  Govt Dental College Kottayam  Department of Conservative Dentistry and Endodontics Room no - 404
Kottayam
KERALA 
9496694158

pcsreelakshmi95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL 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  THE NEGATIVE PRESSURE IRRIGATION SYSTEM  The EV group: In this group, apical negative pressure irrigation will be used. The EndoVac system will be used with 20 mL 2.5% NaOCl during canal preparation, and the macrocannula tip will be used to deliver irrigation up and down the root canal for 30 seconds. This is followed by 3 cycles of microcannula irrigation. Each cycle of microcannula irrigation consists of the tip being placed at the full working length for 6 seconds and then withdrawn 2 mm from the full working length for 6 seconds. This process will be repeated 5 times during a period of 30 seconds, and the final irrigation will be performed with 5 mL 17% EDTA followed by 5 mL distilled water. In both groups, all teeth are then obturated in the same session with gutta-percha and zinc oxide euginol cement using the cold lateral compaction technique. Radiographs will be then taken from different angulations to ensure quality of the obturation. The coronal access cavity is then restored with composite resin (Filtex Z250; 3M ESPE, St Paul, MN), and the occlusion will be checked and adjusted. Each patient is given a prescription for Mefenamic acid (if contraindicated, paracetamol) with instructions to take only if needed for severe pain. 
Comparator Agent  THE POSITIVE PRESSURE IRRIGATION SYSTEM  The conventional needle irrigation (CNI) group: In this group, the irrigation protocol during canal preparation will be performed with 20 mL 2.5% NaOCl using a syringe and a 31-G double-side port needle placed 2 mm short of the working length. The final irrigation will be performed with 5 mL 17 % EDTA followed by 5 mL distilled water. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients with presence of irreversible pulpitis in mandibular first and second molar , without any signs of periapical
involvement  
 
ExclusionCriteria 
Details  Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours
Pregnancy or lactation
Teeth with calcified canals
Teeth with periodontal diseases
Teeth with sensitive to percussion and palpation
Teeth with root resorption
Teeth with immature/open apex
Teeth with previous RCT 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain  4 hours
24 hours
48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
PAIN  12 hours 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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 4 
Date of First Enrollment (India)   25/07/2023 
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="2"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
DISCUSSION
Postoperative pain is an unwanted yet, unfortunately a common sensation after endodontic
treatment. The incidence of postoperative pain was reported to range from 3% to 58%6 . Even severe pain may occur within 24 to 48 hours after therapy5 .After the treatment was finished, 12% of patients experienced severe pain within this time interval according to a visual analog scale (VAS)5. Irritants to the periapical tissues that can evoke pain sensation include medications or irrigating solutions.Antimicrobial debridement is a key step in root canal therapy. Bacteria play a primary role in the development of pulp necrosis, periapical pathosis, and post treatment disease1 . Mechanical instrumentation alone is not enough to render canals free from microorganisms. Several studies have proven the effectiveness of sodium hypochlorite for bacterial reduction in addition to mechanical cleaning and shaping . Sodium hypochlorite works because of its ability to hydrolyze and oxidize cell proteins, its release of free chlorine, and its pH of 11 to 12 . Because of the strong cell toxicity, an associated risk with the use of sodium hypochlorite is the inadvertent injection into the periapical tissues through the apical constriction of the root canal, leading to severe, painful postoperative complications. Sodium hypochlorite accidents have been reported in the literature. Teeth with wide open foramina or with apical constrictions damaged by resorptive processes or by iatrogenic errors during instrumentation are at an elevated risk for the extrusion of sodium hypochlorite. Moreover, if excessive pressure is used during irrigation or the irrigation needle is bound within the root canal and prevents the safe coronal outflow of the solution, large quantities of sodium hypochlorite may be pushed out into the periapical tissues and subsequently lead to tissue necrosis and postoperative pain This causes a dilemma because it is known that a high volume and frequency of irrigation as well as the ability to reach the apical intraradicular tissues are necessary for effective disinfection.To prevent periapical tissue damage and lessen postoperative pain, a safe irrigation delivery system is desirable. Commonly, hypodermic or endodontic needles are used for irrigation. Recently, a new irrigation system, the EndoVac system (Discus Dental, Culver City, CA), was introduced to endodontics. Conventional irrigation works with positive pressure to flush the disinfecting solution into the root canal and force the irrigant out again coronally by displacement with new volumes of solution.The EndoVac system works with negative pressure. Briefly, an irrigation tip is attached to a conventional medical syringe containing the solution. Through this tip, irrigant is released into the pulp chamber. Overflow is prevented by a suction tip that is directly attached to the delivery tip and connects to the high-speed suction of the dental unit. A second tube, connected to the high-speed suction, is used for the attachment of cannulas of varying diameter for different levels of irrigation within the root canal. A stainless steel microcannula of size #32 with 12 small, lateral holes is used for the apical 0 to 3 mm. The tip is inserted to the working length and provides a constant flow of new
irrigation solution to the apical third by sucking it apically from the fresh reservoir in the pulp chamber and disposing the used solution through the evacuation tube toward the high-speed suction of the dental unit


The purpose of the study is to evaluate the post operative pain after 4, 24, and 48 hours and compare the effectiveness of 2 different irrigation techniques that is conventional syringe irrigation and endovac irrigation technique in single visit endodontics. 
Close