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

NCT07578311 | Not Yet Recruiting DMC

• 1 other identifier: EC-MU Research No.1254
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Flare Up, Symptom; Flare up

Keywords

postoperative pain; flare up; intra-canal medication; calcium hydroxide; propolis; Green Tea Polyphenolics

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  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.

• Flare-Up Incidence

  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

Study Arms (3)

Calcium Hydroxide Group

ACTIVE COMPARATOR

Patients receiving conventional Calcium Hydroxide paste as an intracanal medication.

Drug: Calcium hydroxide

Propolis Group

EXPERIMENTAL

Patients receiving a Propolis-based herbal extract as an intracanal medication

Drug: Propolis Extract

Green Tea Group

EXPERIMENTAL

Patients receiving Green Tea Polyphenolics (EGCG) as an intracanal medication.

Drug: Green Tea Polyphenolics (EGCG)

Interventions

Calcium hydroxide DRUG

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.

Calcium Hydroxide Group

Propolis Extract DRUG

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.

Propolis Group

Green Tea Polyphenolics (EGCG) DRUG

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.

Green Tea Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Pain, Postoperative; Symptom Flare Up

Interventions

Calcium Hydroxide; Propolis; epigallocatechin gallate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Recurrence; Disease Attributes

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Central Study Contacts

Abdullah Aiman Ghanemah

CONTACT

+201060493986; abdullah.ghanema@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student - Department of Endodontics

Model Details: participants will be randomly assigned to one of three parallel groups. each group will receive a different intracanal medicament following non surgical root canal retreatment. post operative pain and flare up incidence will be assessed and compared between the three groups.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share