Evaluation of Aerosol in a Dental Clinic

NCT ID: NCT04659928

Last Updated: 2025-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2024-05-02

Brief Summary

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The purpose of this study is to evaluate the effectiveness of external evacuation units and mouth rinses during aerosol generating procedures in a dental clinic and to determine the risk level to the dental practitioners during aerosol generating procedures.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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High volume evacuation (HVE) suction only and hydrogen peroxide

Group Type EXPERIMENTAL

High volume evacuation (HVE)

Intervention Type DEVICE

Intra oral suction will be done and during the procedure,bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given a mouth rinse.

Hydrogen Peroxide

Intervention Type DRUG

Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse

HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide

Group Type EXPERIMENTAL

High volume evacuation (HVE)

Intervention Type DEVICE

Intra oral suction will be done and during the procedure,bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given a mouth rinse.

Extraoral vacuum aspirator (EVA)

Intervention Type DEVICE

Extraoral suction connected to dental suction will be used and bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given mouth rinse.

Hydrogen Peroxide

Intervention Type DRUG

Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse

HVE suction and extraoral vacuum aspirator (EVA) and Placebo

Group Type EXPERIMENTAL

High volume evacuation (HVE)

Intervention Type DEVICE

Intra oral suction will be done and during the procedure,bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given a mouth rinse.

Extraoral vacuum aspirator (EVA)

Intervention Type DEVICE

Extraoral suction connected to dental suction will be used and bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given mouth rinse.

Placebo

Intervention Type DRUG

Subjects will be given a placebo (plain water) mouth rinse

High volume evacuation (HVE) suction only and Placebo

Group Type EXPERIMENTAL

High volume evacuation (HVE)

Intervention Type DEVICE

Intra oral suction will be done and during the procedure,bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given a mouth rinse.

Placebo

Intervention Type DRUG

Subjects will be given a placebo (plain water) mouth rinse

Interventions

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High volume evacuation (HVE)

Intra oral suction will be done and during the procedure,bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given a mouth rinse.

Intervention Type DEVICE

Extraoral vacuum aspirator (EVA)

Extraoral suction connected to dental suction will be used and bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab. Patient will be given mouth rinse.

Intervention Type DEVICE

Hydrogen Peroxide

Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse

Intervention Type DRUG

Placebo

Subjects will be given a placebo (plain water) mouth rinse

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* prepping natural teeth at the appointment
* at least an hour long procedure
* procedure will be the first one in the morning
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Claudia Ruiz Brisuela

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Ruiz Brisuela, DDS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-DB-20-1017

Identifier Type: -

Identifier Source: org_study_id

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