Irreversible PulpitisNCT05811403
Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
A study testing Epigallocatechin gallate (EGCG), Sodium hypochlorite (NaOCl) and Mineral trioxide aggregate (MTA) in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Epigallocatechin gallate (EGCG), Sodium hypochlorite (NaOCl) and Mineral trioxide aggregate (MTA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Irreversible Pulpitis
- Being tested
- Epigallocatechin gallate (EGCG), Sodium hypochlorite (NaOCl), Mineral trioxide aggregate (MTA), Premixed bioceramic putty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 puttyOther
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.
| Study group | Role | What they receive |
|---|---|---|
| EGCG as a flushing fluid, MTA as a pulp capping material | Experimental | Not described Receives: Other: Epigallocatechin gallate (EGCG); Other: Mineral trioxide aggregate (MTA) |
| EGCG as a flushing fluid, Premixed BC putty as a pulp capping material | Experimental | Not described Receives: Other: Epigallocatechin gallate (EGCG); Other: Premixed bioceramic putty |
| NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material | Experimental | Not described Receives: Other: Sodium hypochlorite (NaOCl); Other: Premixed bioceramic putty |
| NaOCl as a flushing fluid, MTA as a pulp capping material | Active comparator | Not described Receives: Other: Sodium hypochlorite (NaOCl); Other: Mineral trioxide aggregate (MTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 72 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anan Medhat Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811403
- Sponsor's protocol ID
- ENDO 372
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05811403
- Acronym / sponsor ID
- ENDO 372
- Conditions
- Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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)Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface. | Other | NaOCl as a flushing fluid, MTA as a pulp capping material, NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material |
| Mineral trioxide aggregate (MTA)Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy. | Other | EGCG as a flushing fluid, MTA as a pulp capping material, NaOCl as a flushing fluid, MTA as a pulp capping material |
| Premixed bioceramic puttyBioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material. | Other | 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 |
Primary outcome
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".
3 secondary outcomes
Clinical success
Time frame: One year follow-up
Radiographic success
Time frame: One year follow-up
Dentin bridge formation
Time frame: 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epigallocatechin gallate (EGCG), Sodium hypochlorite (NaOCl) and Mineral trioxide aggregate (MTA) in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.