Clinical Investigation of Chemomechanical Parameters for an Efficient Disinfection of the Root Canal

Summary

The aim of the study is first, to evaluate the clinical antibacterial efficacy of two different NaOCl concentrations (2,5% and 5%) under a predefined irrigant flow rate in teeth with pulp necrosis and apical periodontitis by using Real-time PCR. . Second, to evaluate the efficacy of final irrigation by assessing, if possible, a numerical definition for that "so called" as "copious irrigation".

Besides the total microbial load, the antibacterial efficacy of final irrigation procedure against two different bacterial species (namely Pseudoramibacter alactolyticus and Treponema denticola) will also be examined.

Conditions

• Apical Periodontitis
• Root Canal Infection

Interventions

PROCEDURE

Root canal tratment using mecchanical and chemical preparation.

Root canal procedures including access cavity preparation, chemomechanical instrumentation, irrigation with sodium hypoclorite (NaOCl), microbiological sampling and obturation with warm vertical compaction.

DRUG

Sodium Hypochlorite.

Sodium Hypoclorite used as the primary irrigant in the root canal treatment at concentrations of 2.5% (Group A) and 5% (Group B).

DRUG

Hydrogen peroxide.

Applied to the operating field and tooth as part of initial disinfection prior to cavity access.

DRUG

Sodium Sulfate.

Used to inactivate sodium hypoclorite prior to sample collection.

DEVICE

Root ZX mini apex locator (Morita).

Used to determine the working length of the root canal.

DEVICE

Protaper Gold rotary files (Dentslpy Maillefer).

Used for coronal flaring in root canal instrumentation.

DEVICE

Smarttrack and Hyflex totary files.

Used for root canal instrumentation to full working length.

DEVICE

Endo-Eze 27G irrigation needle (Ultradent).

Used to deliver irrigant into the root canal.

Sponsors & Collaborators

• National and Kapodistrian University of Athens

  lead OTHER

Principal Investigators

• Giorgos Tzanetakis · National and Kapodistian University of Athens

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2024-12-12

Completion

2025-06-23

Countries

• Greece

Study Locations