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Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures (VKSPCICUDP)

Primary Purpose

SARS-CoV2 Infection, Viral Load, Oral Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non-bloody dental procedures (control group)
Bloody dental procedures (study group)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV2 Infection focused on measuring COVID-19, Viral load, Dental treatment, Intensive care unit

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients between 16 and 90 years old who describe subgingival scaling of at least one dental sextant or a tooth extraction.

Exclusion Criteria: Patients who cannot perform clinical examination and/or open dental procedure.

Sites / Locations

  • Dentistry Unit, Heart Institute, Clinical Hospital of the Faculty of Medicine of the University of São Paulo.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

Study group

Arm Description

Outcomes

Primary Outcome Measures

Increased quantification of viral replication
The performance of bloody dental procedures hospitalized critically ill patients with COVID-19 causes an increase in the quantification of viral replication, causing changes in the patient's clinical outcome

Secondary Outcome Measures

Full Information

First Posted
December 15, 2021
Last Updated
August 2, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05311410
Brief Title
Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures
Acronym
VKSPCICUDP
Official Title
Viral Kinetics of SARS-CoV-2 in Patients in the Intensive Care Unit Undergoing Dental Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
October 20, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The prevalence and clinical relevance of viremia in patients with COVID-19 have not been well investigated. Seeking to understand the need for dentistry to perform bloody procedures in critically ill patients with COVID-19 admitted to the ICU, the quantification of the magnitude of viral replication may play a fundamental role in this scenario. For this, it is necessary to study the viremia kinetics of SARS-CoV-2, seeking to assess whether there is any characteristic pattern that may be associated with a worse clinical outcome of the patient with COVID-19 after undergoing bloody dental procedures, therefore, the objective of this research will be to investigate the occurrence of viral kinetics produced by dental procedures in patients with SARS-CoV-2 in Intensive Care Units, where, in addition to analyzing the oral health condition, the viral kinetics of SARS-CoV-2 will also be investigated by means of reverse transcription polymerase chain reaction (RT-PCR) examination of blood samples from patients with COVID-19 undergoing bloody dental treatment. This research is expected to identify risks and consequences regarding the possibility of performing bloody dental treatment in patients with COVID-19 in serious condition, in addition to verifying the association of the impact of oral infection foci on this profile of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection, Viral Load, Oral Diseases, Dental Treatment
Keywords
COVID-19, Viral load, Dental treatment, Intensive care unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Study group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Non-bloody dental procedures (control group)
Intervention Description
Control group composed of 30 positive patients for SARS-CoV-2, from the same ICU, submitted to non-bloody procedures.
Intervention Type
Procedure
Intervention Name(s)
Bloody dental procedures (study group)
Intervention Description
Study group consisting of 30 patients who require open dental treatment and with a positive PCR test for SARS-CoV-2 prior and admitted to the Intensive Care Unit.
Primary Outcome Measure Information:
Title
Increased quantification of viral replication
Description
The performance of bloody dental procedures hospitalized critically ill patients with COVID-19 causes an increase in the quantification of viral replication, causing changes in the patient's clinical outcome
Time Frame
Through three collections of blood samples, in the following moments: (T0) 15 minutes before the beginning of the dental procedure; (T1) 10 minutes after the start of the procedure; and (T3) 10 minutes after the end of the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 16 and 90 years old who describe subgingival scaling of at least one dental sextant or a tooth extraction. Exclusion Criteria: Patients who cannot perform clinical examination and/or open dental procedure.
Facility Information:
Facility Name
Dentistry Unit, Heart Institute, Clinical Hospital of the Faculty of Medicine of the University of São Paulo.
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itamara LI Neves
Phone
+55 (11)26614142
Email
itamara@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Elói F Matias
Phone
+55 (11)956626714
Email
eloifmatias@usp.br

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the defense of the thesis, the digital file available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo, in portable document format (PDF) file.
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Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures

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