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

Study Overview
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Brief Summary
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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.

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

Conditions
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SARS-CoV2 Infection, Viral Load, Oral Diseases, Dental Treatment

Intervention / Treatment
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* Other: Non-bloody dental procedures (control group)
* Procedure: Bloody dental procedures (study group)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Viral load, Dental treatment, Intensive care unit