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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Other: Epigallocatechin gallate (EGCG)
* Other: Sodium hypochlorite (NaOCl)
* Other: Mineral trioxide aggregate (MTA)
* Other: Premixed bioceramic putty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either gender between the age group of 20-40 years. Systemically healthy patient (ASA I or II). 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. Patients who agree to provide written consent and attend for recall appointments. Exclusion Criteria: Non-restorable teeth with subgingival caries or badly broken teeth. Signs of pulpal necrosis; associated sinus tract or swelling. Negative response to pulp sensibility test. Poor periodontal support. Absence of pulp exposure following complete caries removal. Bleeding from the pulp could not be detected from one or more of the orifices indicating pulp necrosis. Failure to achieve haemostasis within 10 min following full pulpotomy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGCG as a flushing fluid, MTA as a pulp capping material<br> | Other: Epigallocatechin gallate (EGCG)<br>* 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.<br>Other: Mineral trioxide aggregate (MTA)<br>* Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.<br>|
| Experimental: EGCG as a flushing fluid, Premixed BC putty as a pulp capping material<br> | Other: Epigallocatechin gallate (EGCG)<br>* 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.<br>Other: Premixed bioceramic putty<br>* Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.<br>|
| Experimental: NaOCl as a flushing fluid, Premixed BC putty as a pulp capping material<br> | Other: Sodium hypochlorite (NaOCl)<br>* Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.<br>Other: Premixed bioceramic putty<br>* Bioceramic putty is a premixed, ready-to-use calcium silicate-based material which can be used as a pulp capping material.<br>|
| Active Comparator: NaOCl as a flushing fluid, MTA as a pulp capping material<br> | Other: Sodium hypochlorite (NaOCl)<br>* Sodium hypochlorite (NaOCl) is an excellent non-specific proteolytic and antimicrobial agent that provides disinfection of the dentin-pulp interface.<br>Other: Mineral trioxide aggregate (MTA)<br>* Mineral trioxide aggregate (MTA) is the material of choice for pulp capping in vital pulp therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |