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

NCT05988788 | Completed

• 1 other identifier: Epigallocatechin-3-Gallate
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Necrotic Pulp

Keywords

Asymptomatic; Necrotic Mandibular premolar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amount of intracanal bacterial load reduction

  T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min

Study Arms (2)

Epigallocatechin-3-Gallate

EXPERIMENTAL

20% Epigallocatechin-3-Gallate solution

Other: Epigallocatechin-3-gallate

sodium hypochlorite

ACTIVE COMPARATOR

2.5% sodium hypochlorite

Other: sodium hypochlorite

Interventions

Epigallocatechin-3-gallate OTHER

to be used as a root canal irrigant

Also known as: green tea catechin

Epigallocatechin-3-Gallate

sodium hypochlorite OTHER

to be used as a root canal irrigant

sodium hypochlorite

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

epigallocatechin gallate; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• rayan adlan

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 14, 2023
• Study Start: October 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)