Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis

August 21, 2026 updated by: Anan Medhat Mohamed, Cairo University

The Influence of Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy Using Two Different Calcium Silicate-based Materials on Postoperative Pain and Success Rate in Mature Permanent Molars With Irreversible Pulpitis: A Randomized Clinical Trial

This study evaluates the effect of two flushing agents (epigallocatechin gallate (EGCG) and sodium hypochlorite (NaOCl)) during full pulpotomy using two different calcium silicate-based materials (MTA and premixed bioceramic putty) on postoperative pain, success rate and dentin bridge formation in mature permanent mandibular molars with irreversible pulpitis. Participants will be divided into four groups based on the flushing fluid and the pulp capping material to be used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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 Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Cairo University

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients of either gender in the range of 17 to 50 years of age.
  2. Non-contributory medical history (ASA I or II).

  3. Mature permanent mandibular molars with:

    1. Deep caries reaching the inner quarter of dentin or extremely deep caries penetrating the entire thickness of dentin.
    2. Clinical presentation of moderate to severe spontaneous or stimulated lingering pain with healthy periapical tissue (PAI ≤ 2). Pain could be reproduced by cold testing.

Exclusion Criteria:

  1. Non-restorable or badly broken teeth.
  2. Periodontally compromised teeth.
  3. Teeth that were not suitable candidates for class I or class II restorations, and required post and core build-up.
  4. Absence of bleeding from one or more of the orifices after access cavity preparation.
  5. Failure to achieve hemostasis within 10 min following full pulpotomy.
  6. Patients with poor oral hygiene.
  7. Pregnant or nursing females.
  8. Physically or mentally disabled patients.

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
Experimental: EGCG as a flushing fluid, MTA as a pulp capping material
Other: Epigallocatechin gallate (EGCG)
Epigallocatechin gallate (EGCG) is a white powder that can be obtained from tea leaves. It accounts for 50-60 % of catechin content of tea polyphenols with a wide range of biological activities including antioxidant, antimicrobial, anti-inflammatory, immune regulatory, anti-tumour effects.
Other: Mineral trioxide aggregate (MTA)
Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.
Experimental: EGCG as a flushing fluid, Premixed BC putty as a pulp capping material
Other: Epigallocatechin gallate (EGCG)
Epigallocatechin gallate (EGCG) is a white powder that can be obtained from tea leaves. It accounts for 50-60 % of catechin content of tea polyphenols with a wide range of biological activities including antioxidant, antimicrobial, anti-inflammatory, immune regulatory, anti-tumour effects.
Other: Premixed bioceramic putty
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.
Experimental: NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material
Other: Premixed bioceramic putty
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.
Other: Sodium hypochlorite (NaOCl)
Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.
Active Comparator: NaOCl as a flushing fluid, MTA as a pulp capping material
Other: Mineral trioxide aggregate (MTA)
Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.
Other: Sodium hypochlorite (NaOCl)
Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 72 hours
Pain assessments will be made at 24, 48, 72 hours postoperatively using an 11-point NRS. Pain will be categorized into 4 categories as follows: 0 reading represents "no pain"; 1- 3 readings represent "mild pain"; 4- 6 readings represent "moderate pain"; 7- 10 readings represent "severe pain".
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: One year follow-up
The outcome will be considered successful in case of absence of clinical signs and symptoms indicative of pulpal or periapical pathosis (pain and tenderness to percussion). Clinical success will be evaluated at 3, 6 and 12 months.
One year follow-up
Radiographic success
Time Frame: One year follow-up
The outcome will be considered successful in case of normal periapical tissue (PAI score 1 or 2) with absence of any pathosis on recall radiographs such as root resorption. Radiographic success will be evaluated at 3, 6 and 12 months.
One year follow-up
Dentin bridge formation
Time Frame: 12 months follow-up
CBCT scans will be performed at 12 months follow-up to assess the formation of a dentin bridge at the interface between the pulp capping material and the radicular pulp.
12 months follow-up

Collaborators and Investigators

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

Sponsor

Cairo 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 (Actual)

July 1, 2023

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO 372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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