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

NCT ID: NCT05311410

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2025-10-20

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.

Detailed Description

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Conditions

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SARS-CoV2 Infection Viral Load Oral Diseases Dental Treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Group Type ACTIVE_COMPARATOR

Non-bloody dental procedures (control group)

Intervention Type OTHER

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

Study group

Group Type ACTIVE_COMPARATOR

Bloody dental procedures (study group)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Itamara Lucia Itagiba Neves

[email protected]

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Itamara LI Neves

Role: primary

+55 (11)26614142

Elói F Matias

Role: backup

+55 (11)956626714

References

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Other Identifiers

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COVID-Dentistry

Identifier Type: -

Identifier Source: org_study_id

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