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

NCT05811403 | Active Not Recruiting DMC

• 1 other identifier: ENDO 372
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical success

  One year follow-up

• Radiographic success

  One year follow-up

• Dentin bridge formation

  12 months follow-up

Study Arms (4)

EGCG as a flushing fluid, MTA as a pulp capping material

EXPERIMENTAL

Other: Epigallocatechin gallate (EGCG); Other: Mineral trioxide aggregate (MTA)

EGCG as a flushing fluid, Premixed BC putty as a pulp capping material

EXPERIMENTAL

Other: Epigallocatechin gallate (EGCG); Other: Premixed bioceramic putty

NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material

EXPERIMENTAL

Other: Sodium hypochlorite (NaOCl); Other: Premixed bioceramic putty

NaOCl as a flushing fluid, MTA as a pulp capping material

ACTIVE COMPARATOR

Other: Sodium hypochlorite (NaOCl); Other: Mineral trioxide aggregate (MTA)

Interventions

Mineral trioxide aggregate (MTA) OTHER

Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.

EGCG as a flushing fluid, MTA as a pulp capping material; NaOCl as a flushing fluid, MTA as a pulp capping material

Epigallocatechin gallate (EGCG) OTHER

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.

EGCG as a flushing fluid, MTA as a pulp capping material; EGCG as a flushing fluid, Premixed BC putty as a pulp capping material

Sodium hypochlorite (NaOCl) OTHER

Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.

NaOCl as a flushing fluid, MTA as a pulp capping material; NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material

Premixed bioceramic putty OTHER

Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.

EGCG as a flushing fluid, Premixed BC putty as a pulp capping material; NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of either gender between the age group of 20-40 years.
• Systemically healthy patient (ASA I or II).
• 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.
• Patients who agree to provide written consent and attend for recall appointments.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

epigallocatechin gallate; Sodium Hypochlorite; mineral trioxide aggregate

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigator will not be blinded because of the nature of the intervention and comparator (the flushing agent and pulp capping material)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, Ahram Canadian university

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: April 13, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

EG (1)