NCT05100433

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4.7 years

First QC Date

September 20, 2021

Last Update Submit

November 28, 2023

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Bacterial Activity

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

    through study completion, an average of 3 years

Secondary Outcomes (1)

  • Bacterial Levels

    through study completion, an average of 3 years

Study Arms (1)

Microbiological analysis of root canals after endodontic procedures

EXPERIMENTAL

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

Procedure: Ultrasonic irrigation

Interventions

Ultrasonic irrigationPROCEDURE

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

Microbiological analysis of root canals after endodontic procedures

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Teeth with necrotic pulps and asymptomatic apical periodontitis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05508000, Brazil

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 29, 2021

Study Start

March 5, 2018

Primary Completion

November 25, 2022

Study Completion

November 25, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

BR(1)