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Completed

NCT Number: NCT05811403

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

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.

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Key information

Conditions

Irreversible Pulpitis

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of either gender in the range of 17 to 50 years of age.
  • Non-contributory medical history (ASA I or II).
  • Mature permanent mandibular molars with:
  • Deep caries reaching the inner quarter of dentin or extremely deep caries penetrating the entire thickness of dentin.
  • 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

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

Treatment and study plan

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.

Sodium hypochlorite (NaOCl)

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)

Other

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

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.

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2023
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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