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
|
|
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
|
|
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. |