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

NCT ID: NCT05988788

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-07-30

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.

Conditions

Necrotic Pulp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epigallocatechin-3-Gallate

20% Epigallocatechin-3-Gallate solution

Group Type: EXPERIMENTAL

Epigallocatechin-3-gallate

Intervention Type: OTHER

to be used as a root canal irrigant

sodium hypochlorite

2.5% sodium hypochlorite

Group Type: ACTIVE_COMPARATOR

sodium hypochlorite

Intervention Type: OTHER

to be used as a root canal irrigant

Interventions

Epigallocatechin-3-gallate

to be used as a root canal irrigant

Intervention Type: OTHER

sodium hypochlorite

to be used as a root canal irrigant

Intervention Type: OTHER

Other Intervention Names

green tea catechin

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rayan Elsadig Izzeldin

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rayan adlan

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Dentistry

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Epigallocatechin-3-Gallate

Identifier Type: -

Identifier Source: org_study_id