Effect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth

Study Overview
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Brief Summary
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clinically compare the intensity of post-operative pain and the amount of bacterial load reduction after using 20% Epigallocatechin-3-gallate solution during chemomechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.

Detailed Description
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The patients will be randomly divided into 2 groups. Intervention group (20% epigallocatechin-3-gallate solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant). Post-operative pain will be measured at 6, 12, 24 and 48 hours post-operatively. The pain will be recorded using the Numerical Rating Scale (NRS). Amount of bacterial load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.

Official Title
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Effect of Epigallocatechin-3-Gallate Solution Versus Sodium Hypochlorite as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Asymptomatic Necrotic Mandibular Premolars: A Randomized Clinical Trial

Conditions
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Necrotic Pulp

Intervention / Treatment
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* Other: Epigallocatechin-3-gallate
* Other: sodium hypochlorite


Participation Criteria
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Eligibility Criteria
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The inclusion criteria: Systematically healthy patient (ASA I, II). Age between 18 and 45 years Male or female. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis. The exclusion criteria: Medically compromised patients having significant systemic disorders. (ASA III or IV). Teeth with: Immature roots Association with swelling or sinus tract. Acute peri-apical abscess or acute exacerbation of a chronic abscess. Mobility Grade II or III Previously accessed or endodontically treated Deep periodontal pockets more than 4 mm Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions. Patients who could not interpret the NRS.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epigallocatechin-3-Gallate<br>20% Epigallocatechin-3-Gallate solution | Other: Epigallocatechin-3-gallate<br>* to be used as a root canal irrigant<br>* Other names: green tea catechin;|
| Active Comparator: sodium hypochlorite<br>2.5% sodium hypochlorite | Other: sodium hypochlorite<br>* to be used as a root canal irrigant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10 | Postoperative pain measured at 6, 12, 24, 48 hours after single visit treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of intracanal bacterial load reduction | The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation | T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asymptomatic, Necrotic Mandibular premolar