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

NCT05311410 | Unknown DMC

• 1 other identifier: COVID-Dentistry
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection; Viral Load; Oral Diseases; Dental Treatment

Keywords

COVID-19; Viral load; Dental treatment; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: Non-bloody dental procedures (control group)

Study group

ACTIVE COMPARATOR

Procedure: Bloody dental procedures (study group)

Interventions

Non-bloody dental procedures (control group) OTHER

Control group composed of 30 positive patients for SARS-CoV-2, from the same ICU, submitted to non-bloody procedures.

Control group

Bloody dental procedures (study group) PROCEDURE

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.

Study group

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: itamara@incor.usp.br

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: April 5, 2022
• Study Start: September 20, 2021
• Primary Completion: December 20, 2023
• Study Completion: October 20, 2025
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)