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

August 2, 2023 updated by: Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital

Viral Kinetics of SARS-CoV-2 in Patients in the Intensive Care Unit Undergoing Dental Procedures

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Dentistry Unit, Heart Institute, Clinical Hospital of the Faculty of Medicine of the University of São Paulo.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: Non-bloody dental procedures (control group)
Control group composed of 30 positive patients for SARS-CoV-2, from the same ICU, submitted to non-bloody procedures.
Active Comparator: Study group
Procedure: Bloody dental procedures (study group)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased quantification of viral replication
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.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Estimated)

December 20, 2023

Study Completion (Estimated)

October 20, 2025

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-Dentistry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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