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

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

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.

Study Overview

• Status: Completed
• Conditions: Necrotic Pulp
• Intervention / Treatment: Other: Epigallocatechin-3-gallate; Other: sodium hypochlorite

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

The inclusion criteria:

1. Systematically healthy patient (ASA I, II).
2. Age between 18 and 45 years
3. Male or female.
4. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis.

The exclusion criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).

2. 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.
3. Patients who could not interpret the NRS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: rayan adlan, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Asymptomatic; Necrotic Mandibular premolar
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Pain; Pain, Postoperative; Dental Pulp Necrosis; Necrosis; Anti-Infective Agents; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; Neuroprotective Agents; Disinfectants; Antimutagenic Agents; Anticarcinogenic Agents; Sodium Hypochlorite; Eusol; Epigallocatechin gallate
• Other Study ID Numbers: Epigallocatechin-3-Gallate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes