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Completed

NCT Number: NCT02917642

Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals

The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide [LPS]) from root canals.

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Key information

Conditions

Tooth, Nonvital Bacterial Infections Bacterial Infections and Mycoses Dental Pulp Diseases Infections Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the LAL assay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Teeth with necrotic pulps and asymptomatic apical periodontitis

Exclusion criteria

  • patients who had received antibiotics during the previous 3 months or had any general disease,
  • teeth that could not be properly isolated with rubber dam,
  • non-restored teeth,
  • periodontal pockets depths greater than 4 mm,
  • previous endodontic treatment,
  • open apex,
  • crown/root fracture
  • root resorption or calcifications.

Treatment and study plan

Ultrasonic Irrigation

Device

Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file

Non-Ultrasonic Irrigation

Device

Syringe and needle irrigation with no-ultrasonic activation

Primary outcomes

  1. Bacterial Levels

    Time frame: Through study completion, an average of 2 years

    Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay

Secondary outcomes

  1. Endotoxin Levels

    Time frame: Through study completion, an average of 2 years

    Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 28, 2016
Registry last updated
Jul 3, 2018

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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