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OpenTrials
Completed

NCT Number: NCT05988788

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentistry

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients who could not interpret the NRS.

Treatment and study plan

Epigallocatechin-3-gallate

Other

to be used as a root canal irrigant

Other names: green tea catechin

sodium hypochlorite

Other

to be used as a root canal irrigant

Primary outcomes

  1. Postoperative pain

    Time frame: 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 outcomes

  1. Amount of intracanal bacterial load reduction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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