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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100433
• Other study ID #: FAPESP 2016/15473-0-2
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: November 25, 2022

Study information

• Verified date: November 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

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

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Activity	The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation	through study completion, an average of 3 years
Secondary	Bacterial Levels	Quantitative data of total bacteria determined by quantitative polymerase chain reaction after endodontic procedures	through study completion, an average of 3 years