Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High volume evacuation (HVE) suction only and hydrogen peroxide | Experimental |
| |
| HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide | Experimental |
| |
| HVE suction and extraoral vacuum aspirator (EVA) and Placebo | Experimental |
| |
| High volume evacuation (HVE) suction only and Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High volume evacuation (HVE) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Bacterial Colony Forming Units (CFUs) | At baseline (1 hour before treatment), four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room. An impinger will also be positioned 2 ft from the headrest. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The average number of Bacterial CFUs is reported. | Baseline |
| Number of Bacterial Colony Forming Units (CFUs) | At the start of treatment, four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room for one hour. An impinger will also be positioned 2 ft from the headrest for one hour. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The average number of Bacterial CFUs is reported. | 1 hour from the start of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Bacterial Colony Forming Units (CFUs) at Each Location | At baseline (1 hour before treatment), four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room. An impinger will also be positioned 2 ft from the headrest. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The number of Bacterial CFUs per location is reported |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudia Ruiz Brisuela, DDS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | 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. Hydrogen Peroxide: Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse |
| FG001 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | 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. 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. Hydrogen Peroxide: Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse |
| FG002 | High Volume Evacuation (HVE) Suction Only and Placebo | 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse |
| FG003 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | 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. 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | 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. Hydrogen Peroxide: Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Bacterial Colony Forming Units (CFUs) | At baseline (1 hour before treatment), four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room. An impinger will also be positioned 2 ft from the headrest. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The average number of Bacterial CFUs is reported. | Posted | Mean | Standard Deviation | bacterial colony forming units (CFUs) | Baseline |
|
Up to 1 hour
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | 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. Hydrogen Peroxide: Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Ruiz Brisuela, DDS | The University of Texas Health Science Center at Houston | 713-486-4138 | Claudia.RuizBrisuela@uth.tmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2025 | May 27, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D006861 | Hydrogen Peroxide |
| ID | Term |
|---|---|
| D010545 | Peroxides |
| D010087 | Oxides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Extraoral vacuum aspirator (EVA) | 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 | Drug | Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse |
|
| Placebo | Drug | Subjects will be given a placebo (plain water) mouth rinse |
|
| Baseline |
| Number of Bacterial Colony Forming Units (CFUs) at Each Location | At the start of treatment, four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room for one hour. An impinger will also be positioned 2 ft from the headrest for one hour. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The number of Bacterial CFUs per location is reported. | 1 hour from the start of the treatment |
| BG001 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | 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. 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. Hydrogen Peroxide: Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse |
| BG002 | High Volume Evacuation (HVE) Suction Only and Placebo | 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse |
| BG003 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | 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. 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | 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. 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. Hydrogen Peroxide: Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse |
| OG002 | High Volume Evacuation (HVE) Suction Only and Placebo | 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse |
| OG003 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | 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. 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse |
|
|
| Secondary | Number of Bacterial Colony Forming Units (CFUs) at Each Location | At baseline (1 hour before treatment), four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room. An impinger will also be positioned 2 ft from the headrest. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The number of Bacterial CFUs per location is reported | Posted | Mean | Standard Deviation | Bacterial Colony Forming Units (CFUs) | Baseline |
|
|
|
| Secondary | Number of Bacterial Colony Forming Units (CFUs) at Each Location | At the start of treatment, four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room for one hour. An impinger will also be positioned 2 ft from the headrest for one hour. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The number of Bacterial CFUs per location is reported. | Posted | Mean | Standard Deviation | Bacterial Colony Forming Units (CFUs) | 1 hour from the start of the treatment |
|
|
|
| Primary | Number of Bacterial Colony Forming Units (CFUs) | At the start of treatment, four agar petri dishes will be placed at standardized distances (2 ft, 3 ft, 4 ft, and 6 ft) from the dental chair headrest in the operating room for one hour. An impinger will also be positioned 2 ft from the headrest for one hour. The number of bacterial colony-forming units (CFUs) will be counted for each petri dish and the impinger after a 72-hour incubation period. The average number of Bacterial CFUs is reported. | Posted | Mean | Standard Deviation | bacterial colony forming units (CFUs) | 1 hour from the start of the treatment |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | 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. 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. Hydrogen Peroxide: Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | High Volume Evacuation (HVE) Suction Only and Placebo | 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | 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. 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. Placebo: Subjects will be given a placebo (plain water) mouth rinse | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Electrolytes |
| D007287 | Inorganic Chemicals |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Plate 1 (2 feet from dental chair headrest) |
|
| Plate 2 (3 feet from dental chair headrest) |
|
| Plate 3 (4 feet from dental chair headrest) |
|
| Plate 4 (6 feet from dental chair headrest) |
|
| Plate 1 (2 feet from dental chair headrest) |
|
| Plate 2 (3 feet from dental chair headrest) |
|
| Plate 3 (4 feet from dental chair headrest) |
|
| Plate 4 (6 feet from dental chair headrest) |
|