Covid19Phase 4NCT04659928
Evaluation of Aerosol in a Dental Clinic
A Phase 4 study testing High volume evacuation (HVE), Extraoral vacuum aspirator (EVA) and Hydrogen Peroxide in people with Covid19, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- High volume evacuation (HVE), Extraoral vacuum aspirator (EVA) and Hydrogen Peroxide
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 2 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- prepping natural teeth at the appointment
- at least an hour long procedure
- procedure will be the first one in the morning
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Covid19
- Being tested
- High volume evacuation (HVE), Extraoral vacuum aspirator (EVA), Hydrogen Peroxide, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 PeroxideDrug
Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse
PlaceboDrug
Subjects will be given a placebo (plain water) mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| High volume evacuation (HVE) suction only and hydrogen peroxide | Experimental | Not described Receives: Device: High volume evacuation (HVE); Drug: Hydrogen Peroxide |
| HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide | Experimental | Not described Receives: Device: High volume evacuation (HVE); Device: Extraoral vacuum aspirator (EVA); Drug: Hydrogen Peroxide |
| HVE suction and extraoral vacuum aspirator (EVA) and Placebo | Experimental | Not described Receives: Device: High volume evacuation (HVE); Device: Extraoral vacuum aspirator (EVA); Drug: Placebo |
| High volume evacuation (HVE) suction only and Placebo | Experimental | Not described Receives: Device: High volume evacuation (HVE); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour from the start of the treatment
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 hour from the start of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start21 Jul 2021
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Ruiz Brisuela, The University of Texas Health Science Center, Houston
- Investigators
- Claudia Ruiz Brisuela, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659928
- Sponsor's protocol ID
- HSC-DB-20-1017
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2020
- Last updated
- 8 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aerosol in a Dental Clinic
- ClinicalTrials.gov ID
- NCT04659928
- Acronym / sponsor ID
- HSC-DB-20-1017
- Conditions
- Covid19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Posted 8 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High volume evacuation (HVE) suction only and hydrogen peroxide | Experimental | Device: High volume evacuation (HVE), Drug: Hydrogen Peroxide |
| HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide | Experimental | Device: High volume evacuation (HVE), Device: Extraoral vacuum aspirator (EVA), Drug: Hydrogen Peroxide |
| HVE suction and extraoral vacuum aspirator (EVA) and Placebo | Experimental | Device: High volume evacuation (HVE), Device: Extraoral vacuum aspirator (EVA), Drug: Placebo |
| High volume evacuation (HVE) suction only and Placebo | Experimental | Device: High volume evacuation (HVE), Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prepping natural teeth at the appointment
- at least an hour long procedure
- procedure will be the first one in the morning
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | HVE suction and extraoral vacuum aspirator (EVA) and Placebo, HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide, High volume evacuation (HVE) suction only and Placebo, High volume evacuation (HVE) suction only and hydrogen peroxide |
| 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. | Device | HVE suction and extraoral vacuum aspirator (EVA) and Placebo, HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide |
| Hydrogen PeroxideSubjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse | Drug | HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide, High volume evacuation (HVE) suction only and hydrogen peroxide |
| PlaceboSubjects will be given a placebo (plain water) mouth rinse | Drug | HVE suction and extraoral vacuum aspirator (EVA) and Placebo, High volume evacuation (HVE) suction only and Placebo |
Primary outcome
Number of Bacterial Colony Forming Units (CFUs)
Time frame: 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.
Number of Bacterial Colony Forming Units (CFUs)
Time frame: 1 hour from the start of the treatment
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.
2 secondary outcomes
Number of Bacterial Colony Forming Units (CFUs) at Each Location
Time frame: Baseline
Number of Bacterial Colony Forming Units (CFUs) at Each Location
Time frame: 1 hour from the start of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Ruiz Brisuela, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High volume evacuation (HVE), Extraoral vacuum aspirator (EVA) and Hydrogen Peroxide in people with Covid19, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Bacterial Colony Forming Units (CFUs) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.