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

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 thickness 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: Active, not recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Other: Epigallocatechin gallate (EGCG); Other: Mineral trioxide aggregate (MTA); Other: Premixed bioceramic putty; Other: Sodium hypochlorite (NaOCl)

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients of either gender between the age group of 20-40 years.
2. Systemically healthy patient (ASA I or II).

3. Mature permanent mandibular molars with:

   • Extremely deep carious lesion (caries penetrating entire thickness of dentin).
   • Clinical diagnosis of symptomatic irreversible pulpitis and normal periapical tissue.
4. Patients who agree to provide written consent and attend for recall appointments.

Exclusion Criteria:

1. Non-restorable teeth with subgingival caries or badly broken teeth.
2. Signs of pulpal necrosis; associated sinus tract or swelling.
3. Negative response to pulp sensibility test.
4. Poor periodontal support.
5. Absence of pulp exposure following complete caries removal.
6. Bleeding from the pulp could not be detected from one or more of the orifices indicating pulp necrosis.
7. Failure to achieve haemostasis within 10 min following full pulpotomy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

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	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	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	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	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

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): June 30, 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): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Skin Manifestations; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Flushing; Inorganic Chemicals; Chlorine Compounds; Oxides; Oxygen Compounds; Hypochlorous Acid; Sodium Compounds; Sodium Hypochlorite; epigallocatechin gallate; mineral trioxide aggregate
• 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