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

N/AActive Not RecruitingNCT05811403

Cairo University64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Irreversible Pulpitis

Interventions

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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