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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05988788

Enrollment

Registered

2023-08-14

Start date

2023-10-01

Completion date

2024-07-30

Last updated

2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotic Pulp

Keywords

Asymptomatic, Necrotic Mandibular premolar

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.

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.

Interventions

OTHEREpigallocatechin-3-gallate

to be used as a root canal irrigant

OTHERsodium hypochlorite

to be used as a root canal irrigant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Amount of intracanal bacterial load reduction	T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min	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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026