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

Sponsor

University of Sao Paulo (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05100433

Collaborator

(none)

Enrollment

Location

Arm

44.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Procedure: Ultrasonic irrigation	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 5, 2018

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Microbiological analysis of root canals after endodontic procedures Bacterial levels and activity in root canal samples after chemomechanical procedures and ultrasonic irrigation.	Procedure: Ultrasonic irrigation Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.

Arm

Intervention/Treatment

Experimental: Microbiological analysis of root canals after endodontic procedures

Bacterial levels and activity in root canal samples after chemomechanical procedures and ultrasonic irrigation.

Procedure: Ultrasonic irrigation

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

Outcome Measures

Primary Outcome Measures

Bacterial Activity [through study completion, an average of 3 years]
The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation

Secondary Outcome Measures

Bacterial Levels [through study completion, an average of 3 years]
Quantitative data of total bacteria determined by quantitative polymerase chain reaction after endodontic procedures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of São Paulo	São Paulo	SP	Brazil	05508000

Sponsors and Collaborators

University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ericka Tavares Pinheiro, Associate Professor, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT05100433

Other Study ID Numbers:

FAPESP 2016/15473-0-2

First Posted:

Oct 29, 2021

Last Update Posted:

Oct 29, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bacterial Infections

Study Results

No Results Posted as of Oct 29, 2021