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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05988788

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Necrotic Pulp	Other: Epigallocatechin-3-gallate Other: sodium hypochlorite	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.