Effect of a Herbal Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment

May 5, 2026 updated by: Abdulla Aiman Ghanemah, Minia University

Effect Of Phytotherapeutics As Intracanal Medication On Postoperative Pain And Flare up Incidence In Non Surgical Root Canal Retreatment. (Randomized Clinical Trial)

The primary objective of this randomized clinical trial is to evaluate and compare the effectiveness of two natural, herbal-based intracanal medications-Propolis and Green Tea Polyphenolics (EGCG)-against the conventional Calcium Hydroxide in reducing postoperative pain and the incidence of flare-ups during non-surgical root canal retreatment.

Postoperative pain is a common complication in endodontics, particularly in retreatment cases where complex bacterial environments and procedural challenges increase the risk of discomfort and acute flare-ups. While Calcium Hydroxide is the traditional gold standard due to its antimicrobial properties, natural phytotherapeutics like Propolis and Green Tea are being investigated for their potent anti-inflammatory, antioxidant, and antibacterial benefits, which may offer superior biocompatibility and symptomatic relief.

Forty patients requiring endodontic retreatment of single-rooted teeth will be randomly assigned to one of three groups:

Group I (Control): Receives Calcium Hydroxide paste.

Group II: Receives Propolis-based medication.

Group III: Receives Green Tea Polyphenolic-based medication.

The study follows a two-visit protocol. During the first visit, the previous root canal filling is removed, the canal is cleaned and shaped, and the assigned medication is placed. Postoperative pain will be assessed using a Visual Analog Scale (VAS) at 6, 12, 24, 48, 72 hours, and 7 days. Flare-up incidence (sudden severe pain or swelling) will also be monitored. In the second visit, the medication is removed, and the canal is permanently sealed using a bioceramic sealer and gutta-percha. The results will help determine if these herbal alternatives can provide a more comfortable treatment experience for patients undergoing root canal retreatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Failed previously performed endodontic treatment of single-rooted teeth.
  • Presence of a periapical lesion ranging from 1 mm to 2 mm in diameter.
  • Teeth with complete root formation.
  • Teeth without evidence of external or internal root resorption.

Exclusion Criteria:

  • Pregnant females.
  • Patients with uncontrolled systemic diseases.
  • Patients currently under antibiotic or analgesic administration.
  • Patients presenting with facial swelling.
  • Teeth not indicated for endodontic retreatment (e.g., poor oral hygiene, mobile teeth, or recessed teeth).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calcium Hydroxide Group
Patients receiving conventional Calcium Hydroxide paste as an intracanal medication.
Drug: Calcium hydroxide
Following chemo-mechanical preparation and canal drying, Calcium Hydroxide paste is inserted into the root canal using a specialized syringe. The material is placed 0.5-1 mm from the apex to ensure complete filling without extrusion. It remains in the canal until the second visit for obturation.
Experimental: Propolis Group
Patients receiving a Propolis-based herbal extract as an intracanal medication
Drug: Propolis Extract
After cleaning, shaping, and drying the root canal, a Propolis-based natural resinous substance is used as an intracanal medication. The material is delivered via syringe to a depth of 0.5-1 mm from the apex. This herbal medicament is utilized for its antimicrobial and anti-inflammatory properties.
Experimental: Green Tea Group
Patients receiving Green Tea Polyphenolics (EGCG) as an intracanal medication.
Drug: Green Tea Polyphenolics (EGCG)
Following the standardized cleaning protocol and canal drying, Green Tea Polyphenolics (EGCG) extract is inserted as an intracanal medication. The extract is placed 0.5-1 mm from the apex using a syringe. It serves as an herbal antioxidant and antimicrobial agent during the inter-appointment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flare-Up Incidence
Time Frame: Within 7 days post-treatment

Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place.

This could require an unscheduled emergency visit or prescription of additional medication.
Within 7 days post-treatment
Postoperative pain
Time Frame: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.

Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10" means a severe pain that has never faced before.

Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.
6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-MU Research No.1254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) will not be shared due to privacy concerns and the limited scope of data use approved by the ethics committee. The study is designed for internal analysis only and does not include provisions for public data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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