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Completed

NCT Number: NCT05100433

Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation

This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root canal disinfection after chemomechanical procedures.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo

São Paulo, 05508000, Brazil

About this study

Although chemomechanical procedures promote a drastic bacterial reduction, many root canals remain infected, which points to the need for complementary procedures to improve root canal disinfection. Thus, this clinical study aims to evaluate the effect of passive ultrasonic irrigation as a supplementary disinfection procedure after root canal preparation. Microbiological samples of the root canals of 30 single-rooted teeth with apical periodontitis will be taken at different stages of the endodontic treatment: before preparation (S1), after chemomechanical procedures (S2) and after passive ultrasonic irrigation (S3). The samples will be submitted to the quantitative polymerase chain reaction for bacterial quantification and to the reverse transcription quantitative polymerase chain reaction for bacterial activity analysis. Data will be analyzed using the Wilcoxon test for paired samples (p < 0.05).

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

Procedure

Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.

Primary outcomes

  1. Bacterial Activity

    Time frame: through study completion, an average of 3 years

    The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation

Secondary outcomes

  1. Bacterial Levels

    Time frame: through study completion, an average of 3 years

    Quantitative data of total bacteria determined by quantitative polymerase chain reaction after endodontic procedures

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation in Teeth With Apical Periodontitis

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2021
Registry last updated
Nov 29, 2023

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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