CTRI

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CTRI Number

CTRI/2026/03/105830 [Registered on: 10/03/2026] Trial Registered Prospectively

Last Modified On:

10/03/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Effect of root canal irrigants on post operative pain after root canal treatment.

Scientific Title of Study

Comparative evaluation of the effect of Hydroxyethylidene bisphosphonate (HEBP)-Sodium hypochlorite and neem leaf extract as root canal irrigants on post operative pain in 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	Avishkar Dhanraj Patil
Designation	PG MDS Student
Affiliation	Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Hingna Nagpur Maharashtra
Address	Maple Enclave Apartments Teachers Colony Wanadongri Nagpur MAHARASHTRA 441110 India
Phone	9975597632
Fax
Email	patiosdavi@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ambar Raut
Designation	Professor & HOD
Affiliation	Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Hingna Nagpur Maharashtra
Address	Swargiya Dadasaheb Kalmegh Smruti Dental College & Hospital Hingna Nagpur Nagpur MAHARASHTRA 441110 India
Phone	7757805056
Fax
Email	ambar.raut@sdk-dentalcollege.edu.in

Details of Contact Person
Public Query

Name	Avishkar Dhanraj Patil
Designation	PG MDS Student
Affiliation	Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Hingna Nagpur Maharashtra
Address	Maple Enclave Apartments Teachers Colony Wanadongri Nagpur MAHARASHTRA 441110 India
Phone	9975597632
Fax
Email	patiosdavi@gmail.com

Source of Monetary or Material Support

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital

Primary Sponsor

Name	Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital
Address	Sangam Road Hingna Nagpur Maharashtra 441110
Type of Sponsor	Private medical college

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 Avishkar Patil	Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital	Sangam road, Hingna, Nagpur 441110 Department of Conservative Dentistry & Endodontics Department No 206 3rd Floor Nagpur MAHARASHTRA	9975597632 patiosdavi@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SDKS Dental College 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. Ayurveda Condition: DANTAMULAGATAROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm (Non Ayurveda)		-	Sodium Hypochlorite with EDTA	It is a conventional root canal irrigant, it is used in concerntration of 3% of sodium hypochlorite and 17% EDTA
2	Comparator Arm (Non Ayurveda)		-	Hydroxyethylidene bisphosphonate (HEBP)-Sodium hypochlorite	A premeasured amount of 0.9mg (2 capsules) of HEBP powder will be added directly to the 10ml of 3% sodium hypochlorite solution Final mixture will contain 9% of HEBP
3	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Neem leaf extract, Reference: NA, Route: Topical, Dosage Form: Swaras/ Juice, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Mature fresh Neem (Azadirachta indica) leaves will be collected and washed in sterilized distilled water and dried. Ethanolic Neem extract will be prepared by macerating 150g of dry weight powder of Neem leaves with 300mL of 95% (w/v) ethyl alcohol for a week in a round bottom flask with occasional shaking. The flask will be kept in a dark environment to avoid the effect of light on the active ingredients of Neem. The extract will be then filtered through a muslin cloth and finally through Whatman No.1 filter paper. Alcohol will be removed using Rota-vapor under reduced pressure and kept in the desiccators overnight. The residue will be then dissolved in 300 mL of 9.99% Dimethyl Sulfoxide (DMSO) to make the final 50% concentration and will be kept in the refrigerator. During canal preparation, each canal will be irrigated with 3ml of Neem leaf extract during each instrumentation and as final rinse for 1 min.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1.Patients requiring endodontic therapy of mandibular molars teeth diagnosed with symptomatic irreversible pulpitis with or without associated apical periodontitis 2.Systemically healthy patients presenting with moderate to severe pain, with a Visual Analog Scale (VAS) score ranging from 3 to 10 (on a 0–10 scale) 3.Systemicallly healthy patients aged between 18 and 55 years who provided written informed consent. 4.Teeth exhibiting tenderness on percussion but without well-defined periapical radiographic changes.

ExclusionCriteria

Details

1.Medically compromised patients.
2.Teeth exhibiting clearly defined periapical radiolucency, calcified root canals, associated with a
sinus tract and periapical abscess.
3.Teeth with incomplete apex formation
4.Patients under analgesic medication at the time of assessment.
5.Patient on antibiotic therapy.
6.Pregnant or lactating patients.
7.Patients failure to report for follow-up visits.
8.Patients unable to comply with post-operative pain assessment protocols (e.g., incomplete VAS
records).

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Post operative pain measurement after endodontic treatment using Numeric Rating scale.	6Hrs, 24Hrs, 48Hrs

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="63"
Sample Size from India="63"
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/ Phase 4

Date of First Enrollment (India)

01/12/2026

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="0"
Months="8"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

Post-endodontic pain is a significant factor influencing the overall success of root canal therapy. It may result from microbial, mechanical, or chemical factors, including apical extrusion of debris, irrigants, or medicaments during instrumentation. Effective root canal treatment requires thorough debridement, smear layer removal, and three-dimensional obturation while ensuring minimal postoperative discomfortSodium hypochlorite (NaOCl) is widely used for its antimicrobial and tissue-dissolving properties but does not remove the smear layer; therefore, chelating agents such as EDTA are commonly used as adjuncts. However, conventional NaOCl–EDTA protocols may contribute to dentin erosion and postoperative pain. Etidronic acid (HEBP), a soft chelating agent, can be used in combination with NaOCl as a continuous chelator and may offer improved biocompatibility with reduced dentin erosion. Herbal alternatives such as Neem (Azadirachta indica) leaf extract possess antimicrobial and anti-inflammatory properties and may potentially reduce postoperative discomfort, though clinical evidence remains limited.This study is designed to evaluate and compare the effect of three final irrigating regimens—NaOCl with EDTA, NaOCl with HEBP, and Neem leaf extract—on postoperative pain in patients diagnosed with symptomatic irreversible pulpitis. The objective is to identify an irrigating protocol that ensures effective disinfection while minimizing postoperative pain and improving patient comfort.