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

Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811403
• Other study ID #: ENDO 372
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Anan Medhat
• Phone: 01098708303
• Email: Anan.Medhat[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flushing
• Irreversible Pulpitis
• Pulpitis

Intervention

Other:
• 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.
• Sodium hypochlorite (NaOCl)
Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.
• Mineral trioxide aggregate (MTA)
Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.
• Premixed bioceramic putty
Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Pain assessments will be made at 24, 48, 72 hours and one week 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".	One week
Secondary	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).	One year follow-up
Secondary	Radiographic success	The outcome will be considered successful in case of complete radiographic healing (PAI score 1 or 2) with absence of any pathosis on recall radiographs such as root resorption.	One year follow-up
Secondary	Dentin bridge thickness	CBCT scans will be performed at 12 months to measure the thickness of the dentin bridge formed at the interface between the pulp capping material and the radicular pulp.	12 months