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CompletedNCT05811403Updated Aug 24, 2026

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

An interventional study of Epigallocatechin gallate (EGCG) and Sodium hypochlorite (NaOCl) in Irreversible Pulpitis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 17 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
17 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Irreversible Pulpitis
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

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

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

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

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

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

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

  • Active comparator
    NaOCl as a flushing fluid, MTA as a pulp capping material

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

Interventions

  • OtherEpigallocatechin 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.

  • OtherSodium hypochlorite (NaOCl)

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

  • OtherMineral trioxide aggregate (MTA)

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

  • OtherPremixed bioceramic putty

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

06

What researchers measure

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".

    Time frame: 72 hours

Secondary outcomes

  1. 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.

    Time frame: One year follow-up

  2. 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.

    Time frame: One year follow-up

  3. 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.

    Time frame: 12 months follow-up

07

Study locations

1 site
  • Faculty of Dentistry, Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05811403
Lead sponsor
Cairo University
Responsible party
Anan Medhat Mohamed (Assistant lecturer, Ahram Canadian university, Cairo University) — Principal investigator
First posted
Apr 13, 2023
Start date
Jul 1, 2023
Primary completion
Jun 30, 2025
Completion
Jun 1, 2026
Last update
Aug 24, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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