Evaluation of Aerosol in a Dental Clinic
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 covid19
Started Jul 2021
Longer than P75 for phase_4 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 9, 2020
CompletedStudy Start
First participant enrolled
July 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2024
CompletedResults Posted
Study results publicly available
July 8, 2025
CompletedJuly 8, 2025
June 1, 2025
2.8 years
November 30, 2020
June 18, 2025
June 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Number of Bacterial Colony Forming Units (CFUs) at Each Location
Baseline
Number of Bacterial Colony Forming Units (CFUs) at Each Location
1 hour from the start of the treatment
Study Arms (4)
High volume evacuation (HVE) suction only and hydrogen peroxide
EXPERIMENTALHVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide
EXPERIMENTALHVE suction and extraoral vacuum aspirator (EVA) and Placebo
EXPERIMENTALHigh volume evacuation (HVE) suction only and Placebo
EXPERIMENTALInterventions
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 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
Subjects will be given a placebo (plain water) mouth rinse
Eligibility Criteria
You may qualify if:
- prepping natural teeth at the appointment
- at least an hour long procedure
- procedure will be the first one in the morning
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Claudia Ruiz Brisuela, DDS
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia Ruiz Brisuela, DDS
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 9, 2020
Study Start
July 21, 2021
Primary Completion
May 2, 2024
Study Completion
May 2, 2024
Last Updated
July 8, 2025
Results First Posted
July 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share