| CTRI Number |
CTRI/2025/08/092627 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Irrigation Techniques for Root Canal Treatment: A Study on Pain Relief and Cleaning Effectiveness of Different Root Canal Irrigants in Adult Teeth with Dead Pulp |
|
Scientific Title of Study
|
Comparative Evaluation of the Depth of Penetration and Postoperative Pain Associated with the Use of Standard Irrigation Protocol and Continuous Chelation Using HEBP with and Without the Use of Ultrasonic Activation in the Endodontic Treatment of Adult Permanent Teeth with Necrotic Pulp A Randomized Controlled 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 |
Dr Krishma Mehra |
| Designation |
Post Graduate Student |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics, Himachal Dental college and hospital, Sunder Nagar, District Mandi
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
09736066980 |
| Fax |
01907267183 |
| Email |
Krishma.mehra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munish Goel |
| Designation |
Professor and Head of Department |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics, Himachal Dental college and hospital, Sunder Nagar, District Mandi
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9816034034 |
| Fax |
01907267183 |
| Email |
goelmuni2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Munish Goel |
| Designation |
Professor and Head of Department |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics, Himachal Dental college and hospital, Sunder Nagar, District Mandi
Mandi
HIMACHAL PRADESH
175019
India |
| Phone |
9816034034 |
| Fax |
01907267183 |
| Email |
goelmuni2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and endodontics, Himachal Dental College and Hospital, Sundarnagar, Mandi, Himachal Pradesh, 175019 |
|
|
Primary Sponsor
|
| Name |
Dr. Krishma Mehra |
| Address |
Department of conservative dentistry and endodontics, Himachal Dental college and hospital, Sunder Nagar, District Mandi |
| 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 Krishma Mehra |
Himachal Dental College and Hospital |
Department of Conservative Dentistry and Endodontics Himachal Dental College and Hospital Sundernagar
Mandi
HIMACHAL PRADESH |
09736066980
01907267183
Krishma.mehra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Himachal Dental College and Hospital Sundernagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous chelation
using HEBP with ultrasonic
activation |
Final irrigation with 9 percent
HEBP 3 percent NaOCl,
followed by the use of
saline
Irrigant solution will be
ultrasonically agitated with
an ultrasonic activator |
| Intervention |
Continuous chelation using HEBP |
Canal irrigation with 9 percent HEBP 3 percent NaOCl after the use of each file |
| Comparator Agent |
Standard Irrigation with EDTA during Root canal treatment |
Canal irrigation with 3%
NaOCl after the use of
each file
17% EDTA will be used,
followed by saline for
avoiding potential carry-over
effects of the irrigant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adult permanent asymptomatic teeth with necrotic pulp requiring non
surgical endodontic treatment
Teeth whose non-vitality was confirmed by an electric pulp tester (EPT)
and thermal sensitivity testing
Feasibility of isolating the tooth with a rubber dam
Vertucci Type I and Type IV root canal anatomy
Participants with the ability to understand the consent forms and the pain
record scales |
|
| ExclusionCriteria |
| Details |
Nonvital tooth with periapical lesion
Patients with spontaneous preoperative pain
Patients who had taken Nonsteroidal anti-inflammatory drugs or any other
analgesic for pain within the last 4–8 h
Teeth with calcified root canals and complex root canal anatomy.
Teeth with open apices, and resorbed apex
Periodontally compromised teeth
The patient who is not willing to give consent for the study
Patients with known allergies to the materials used in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed on clinical evaluation and radiographic assessment |
6 hours and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed on clinical evaluation and radiographic assessment |
During treatment |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/09/2025 |
| 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="1"
Days="0" |
|
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
|
The study compares traditional NaOCl/EDTA sequential irrigation with continuous chelation using HEBP and NaOCl, with or without ultrasonic activation, in adult teeth with necrotic pulp. Mechanical instrumentation alone may leave 35% of the canal untouched, so irrigants are vital. Continuous chelation simplifies procedures and maintains NaOCl’s antibacterial potency while reducing structural damage. The goal is to assess which method offers deeper irrigant penetration and minimizes postoperative pain. |