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

NCT ID: NCT05811403

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The investigator will not be blinded because of the nature of the intervention and comparator (the flushing agent and pulp capping material)

Study Groups

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

Group Type EXPERIMENTAL

Epigallocatechin gallate (EGCG)

Intervention Type 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.

Mineral trioxide aggregate (MTA)

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Epigallocatechin gallate (EGCG)

Intervention Type 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.

Premixed bioceramic putty

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Sodium hypochlorite (NaOCl)

Intervention Type OTHER

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

Premixed bioceramic putty

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Sodium hypochlorite (NaOCl)

Intervention Type OTHER

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

Mineral trioxide aggregate (MTA)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Sodium hypochlorite (NaOCl)

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

Intervention Type OTHER

Mineral trioxide aggregate (MTA)

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Anan Medhat Mohamed

Assistant lecturer, Ahram Canadian university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ENDO 372

Identifier Type: -

Identifier Source: org_study_id

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