VKSPCICUDP: Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures
Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05311410
Collaborator
(none)
60
1
2
49
1.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Viral Kinetics of SARS-CoV-2 in Patients in the Intensive Care Unit Undergoing Dental Procedures
Actual Study Start Date
:
Sep 20, 2021
Anticipated Primary Completion Date
:
Oct 20, 2023
Anticipated Study Completion Date
:
Oct 20, 2025
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Increased quantification of viral replication [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dentistry Unit, Heart Institute, Clinical Hospital of the Faculty of Medicine of the University of São Paulo. | São Paulo | Brazil | 05403-900 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT05311410
Other Study ID Numbers:
- COVID-Dentistry
First Posted:
Apr 5, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Sao Paulo General Hospital
Additional relevant MeSH terms: