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

Tooth, Nonvital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917642
• Other study ID #: FAPESP2013/02923-9
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• 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

• Tooth, Nonvital

Intervention

Device:
• Ultrasonic Irrigation
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
Syringe and needle irrigation with no-ultrasonic activation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Levels	Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay	Through study completion, an average of 2 years
Secondary	Endotoxin Levels	Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay	Through study completion, an average of 2 years