Covid19
Conditions
Brief summary
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.
Interventions
DEVICEHigh 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.
DEVICEExtraoral 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.
Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse
DRUGPlacebo
Subjects will be given a placebo (plain water) mouth rinse
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* prepping natural teeth at the appointment * at least an hour long procedure * procedure will be the first one in the morning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Bacterial Colony Forming Units (CFUs) | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Bacterial Colony Forming Units (CFUs) at Each Location | Baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| 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 | 11 |
| 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 | 10 |
| Total | 41 |
Baseline characteristics
| Characteristic | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Total | High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | High Volume Evacuation (HVE) Suction Only and Placebo |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 15 Participants | 6 Participants | 4 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 26 Participants | 4 Participants | 6 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — | — |
| Region of Enrollment United States | 10 participants | 41 participants | 10 participants | 10 participants | 11 participants |
| Sex: Female, Male Female | 5 Participants | 17 Participants | 3 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 24 Participants | 7 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) | 47.2 bacterial colony forming units (CFUs) | Standard Deviation 16.38 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) | 125.3 bacterial colony forming units (CFUs) | Standard Deviation 155.43 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) | 70.7 bacterial colony forming units (CFUs) | Standard Deviation 98.06 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) | 116.7 bacterial colony forming units (CFUs) | Standard Deviation 143.38 |
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.
Time frame: 1 hour from the start of the treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) | 101.3 bacterial colony forming units (CFUs) | Standard Deviation 131.9 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) | 87.1 bacterial colony forming units (CFUs) | Standard Deviation 101 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) | 45.7 bacterial colony forming units (CFUs) | Standard Deviation 15.28 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) | 52.44 bacterial colony forming units (CFUs) | Standard Deviation 17.89 |
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
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 10.7 Bacterial Colony Forming Units (CFUs) | Standard Deviation 6.37 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 13 Bacterial Colony Forming Units (CFUs) | Standard Deviation 8.51 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 10.6 Bacterial Colony Forming Units (CFUs) | Standard Deviation 7.84 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 12.3 Bacterial Colony Forming Units (CFUs) | Standard Deviation 9.63 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 0.6 Bacterial Colony Forming Units (CFUs) | Standard Deviation 0.96 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 7.3 Bacterial Colony Forming Units (CFUs) | Standard Deviation 5.51 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 66.2 Bacterial Colony Forming Units (CFUs) | Standard Deviation 123.33 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 7.6 Bacterial Colony Forming Units (CFUs) | Standard Deviation 6.07 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 10.8 Bacterial Colony Forming Units (CFUs) | Standard Deviation 8.53 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 33.4 Bacterial Colony Forming Units (CFUs) | Standard Deviation 93.86 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 40.66 Bacterial Colony Forming Units (CFUs) | Standard Deviation 97.39 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 2.22 Bacterial Colony Forming Units (CFUs) | Standard Deviation 3.34 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 9.22 Bacterial Colony Forming Units (CFUs) | Standard Deviation 5.38 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 9 Bacterial Colony Forming Units (CFUs) | Standard Deviation 6.72 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 9.66 Bacterial Colony Forming Units (CFUs) | Standard Deviation 6.63 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 11.66 Bacterial Colony Forming Units (CFUs) | Standard Deviation 14.8 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 18.44 Bacterial Colony Forming Units (CFUs) | Standard Deviation 30.61 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 35.11 Bacterial Colony Forming Units (CFUs) | Standard Deviation 99.36 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 11.11 Bacterial Colony Forming Units (CFUs) | Standard Deviation 5.27 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 40.44 Bacterial Colony Forming Units (CFUs) | Standard Deviation 97.47 |
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.
Time frame: 1 hour from the start of the treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 10.8 Bacterial Colony Forming Units (CFUs) | Standard Deviation 8.1 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 31.4 Bacterial Colony Forming Units (CFUs) | Standard Deviation 94.39 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 40.3 Bacterial Colony Forming Units (CFUs) | Standard Deviation 91.59 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 9.4 Bacterial Colony Forming Units (CFUs) | Standard Deviation 4.5 |
| High Volume Evacuation (HVE) Suction Only and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 9.4 Bacterial Colony Forming Units (CFUs) | Standard Deviation 5.31 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 14.5 Bacterial Colony Forming Units (CFUs) | Standard Deviation 16.09 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 16.9 Bacterial Colony Forming Units (CFUs) | Standard Deviation 28.33 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 11.3 Bacterial Colony Forming Units (CFUs) | Standard Deviation 8.05 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 31.3 Bacterial Colony Forming Units (CFUs) | Standard Deviation 94.43 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Hydrogen Peroxide | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 13.1 Bacterial Colony Forming Units (CFUs) | Standard Deviation 12.99 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 7.9 Bacterial Colony Forming Units (CFUs) | Standard Deviation 6.06 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 2.9 Bacterial Colony Forming Units (CFUs) | Standard Deviation 3.34 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 11.5 Bacterial Colony Forming Units (CFUs) | Standard Deviation 6.98 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 13.2 Bacterial Colony Forming Units (CFUs) | Standard Deviation 11.28 |
| High Volume Evacuation (HVE) Suction Only and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 10.2 Bacterial Colony Forming Units (CFUs) | Standard Deviation 3.11 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 4 (6 feet from dental chair headrest) | 12.33 Bacterial Colony Forming Units (CFUs) | Standard Deviation 8.42 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 3 (4 feet from dental chair headrest) | 12.22 Bacterial Colony Forming Units (CFUs) | Standard Deviation 8.54 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 1 (2 feet from dental chair headrest) | 12.33 Bacterial Colony Forming Units (CFUs) | Standard Deviation 7.46 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Impinger (2 feet from dental chair headrest) | 3.44 Bacterial Colony Forming Units (CFUs) | Standard Deviation 5.36 |
| HVE Suction and Extraoral Vacuum Aspirator (EVA) and Placebo | Number of Bacterial Colony Forming Units (CFUs) at Each Location | Plate 2 (3 feet from dental chair headrest) | 12.11 Bacterial Colony Forming Units (CFUs) | Standard Deviation 9.58 |