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

Necrotic Pulp Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05988788
• Other study ID #: Epigallocatechin-3-Gallate
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: rayan adlan, BDS
• Phone: +201117801699
• Email: rayan.elsadig[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp
• Pain
• Pain, Postoperative

Intervention

Other:
• Epigallocatechin-3-gallate
to be used as a root canal irrigant
• sodium hypochlorite
to be used as a root canal irrigant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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