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

Primary Purpose

Bacterial Infections

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ultrasonic irrigation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microbiological analysis of root canals after endodontic procedures

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2021
Last Updated
October 18, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05100433
Brief Title
Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation
Official Title
Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation in Teeth With Apical Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microbiological analysis of root canals after endodontic procedures
Arm Type
Experimental
Arm Description
Bacterial levels and activity in root canal samples after chemomechanical procedures and ultrasonic irrigation.
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic irrigation
Intervention Description
Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.
Primary Outcome Measure Information:
Title
Bacterial Activity
Description
The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation
Time Frame
through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Bacterial Levels
Description
Quantitative data of total bacteria determined by quantitative polymerase chain reaction after endodontic procedures
Time Frame
through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05508000
Country
Brazil

12. IPD Sharing Statement

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

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