| CTRI Number |
CTRI/2026/02/102829 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Root Canal Cleaning Methods on Cleaning Depth and Post-Treatment Pain in Lower Molars |
|
Scientific Title of Study
|
Comparative evaluation of depth of penetration of Irrigant and postoperative pain associated with Hebp/naocl versus naocl/edta in permanent Mandibular molars with symptomatic irreversible Pulpitis -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 Simran Bansal |
| Designation |
Post graduate student |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of Conservative dentistry and Endodontics. Room no. 3.
Yamunanagar
HARYANA
135001
India |
| Phone |
9896577948 |
| Fax |
|
| Email |
bansalsimran9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bogra |
| Designation |
Professor and head of department |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of Conservative dentistry and Endodontics. Room no. 3.
Yamunanagar
HARYANA
135001
India |
| Phone |
9050462962 |
| Fax |
|
| Email |
poonambogra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Bansal |
| Designation |
Post graduate student |
| Affiliation |
J.N Kapoor DAV(c) Dental college |
| Address |
Department of Conservative dentistry and Endodontics. Room no. 3.
Yamunanagar
HARYANA
135001
India |
| Phone |
9896577948 |
| Fax |
|
| Email |
bansalsimran9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JN Kapoor Dav Dental College Yamunanagar |
| Address |
JN Kapoor Dav dental college, model town yamunanagar 135001 |
| Type of Sponsor |
Other [Private Dental college] |
|
|
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 Simran Bansal |
J N Kapoor DAV Dental college, Yamunanagar |
Department of Conservative Dentistry and Endodontics, Room no 3
Yamunanagar
HARYANA |
9896577948
bansalsimran9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| J N Kapoor DAV Dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Depth of penetration and postoperative pain in HEBP+NaOCl and NaOCl/EDTA |
Postoperative pain in HEBP+NaOCl and NaOCl/EDTA at 24hr,48hr and 1 week |
| Intervention |
HEBP+NaOCl |
Twin kleen |
| Intervention |
Naocl/Edta |
Prevest |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the ages of 18 and 50 years
2. Patients with diagnosis of symptomatic irreversible pulpitis in mandibular molars.
3. Teeth with pain score greater than 54 mm on Heft Parker visual analogue scale.
4. Healthy patients with ASAI and ASA II
5. Feasibility of isolating the tooth with a rubber dam.
6. Participants with the ability to understand the consent forms and the pain record scales.
|
|
| ExclusionCriteria |
| Details |
1. Non vital mandibular molars.
2. Teeth with calcified root canals, complex root canal anatomy and internal/external resorption.
3. Previously initiated root canal treatment.
4. Patients who had taken any analgesics or CNS depressents till before 12 hours of the treatment.
5. Mobile Teeth.
6. Teeth with pathologic periodontal pockets during probing.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Depth of Penetration of irrigant, Postoperative Pain and Analgesic intake
|
24 hours, 48 hours and 1 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2026 |
| 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)
|
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
|
RESEARCH QUESTION 1. What is the penetration index, incidence and intensity of postoperative pain and analgesic intake when irrigation is done with continuous chelation using HEBP/NaOCl in permanent mandibular molars with symptomatic irreversible pulpitis? 2. What is the penetration index, incidence and intensity of postoperative pain and analgesic intake when irrigation is done with sequential chelation using NaOCl/EDTA in permanent mandibular molars with symptomatic irreversible pulpitis? 3. Is there any difference in penetration index, incidence and intensity of postoperative pain and analgesic intake when irrigation is done with continuous chelation using HEBP/NaOCl and sequential chelation using NaOCl/EDTA in permanent mandibular molars with symptomatic irreversible pulpitis? Population: 60 permanent mandibular molars with symptomatic irreversible pulpitis in patients between the age group of 18-50 years. Intervention: Irrigation done with continuous chelation using HEBP/NaOCl. Control group: Irrigation done with sequential chelation using NaOCl/EDTA. Outcome: Depth of penetration, Postoperative pain and analgesic requirement in mandibular molars with symptomatic irreversible pulpitis when irrigation will be done with continuous chelation using HEBP/NaOCl and to compare the results with irrigation done with sequential chelation using NaOCl/EDTA as a control group.
AIM: The aim of this randomized controlled trial will be to evaluate and compare the depth of penetration of irrigant and postoperative pain associated with the use of continuous chelation using HEBP/NaOCl and sequential chelation using NaOCl/EDTA in the endodontic treatment of permanent mandibular molars with symptomatic irreversible pulpitis. OBJECTIVES: 1. To evaluate depth of penetration of irrigant, postoperative pain and analgesic requirement after irrigation with continuous chelation using HEBP/NaOCl during root canal treatment of mandibular molars with symptomatic irreversible pulpitis. 2. To evaluate depth of penetration of irrigant, postoperative pain and analgesic requirement after irrigation with sequential chelation using NaOCl/EDTA during root canal treatment of mandibular molars with symptomatic irreversible pulpitis. 3. To compare the above-mentioned parameters.
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