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

Not Applicable

Recruiting

• Conditions: Irreversible Pulpitis
• Interventions: Other: Sodium hypochlorite (NaOCl); Other: Epigallocatechin gallate (EGCG); Other: Mineral trioxide aggregate (MTA); Other: Premixed bioceramic putty

• Registration Number: NCT05811403
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-13
• Study Start: 2023-07-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGCG as a flushing fluid, MTA as a pulp capping material	Mineral trioxide aggregate (MTA)	-
EGCG as a flushing fluid, Premixed BC putty as a pulp capping material	Premixed bioceramic putty	-
NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material	Premixed bioceramic putty	-
NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material	Sodium hypochlorite (NaOCl)	-
EGCG as a flushing fluid, MTA as a pulp capping material	Epigallocatechin gallate (EGCG)	-
EGCG as a flushing fluid, Premixed BC putty as a pulp capping material	Epigallocatechin gallate (EGCG)	-
NaOCl as a flushing fluid, MTA as a pulp capping material	Sodium hypochlorite (NaOCl)	-
NaOCl as a flushing fluid, MTA as a pulp capping material	Mineral trioxide aggregate (MTA)	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain	One week	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".

Secondary Outcome Measures

Name	Time	Method
Clinical success	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).
Radiographic success	One year follow-up	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.
Dentin bridge thickness	12 months	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt