NCT04659928

Evaluation of Aerosol in a Dental Clinic

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DEVICE	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	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.
DRUG	Hydrogen Peroxide	Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse
DRUG	Placebo	Subjects will be given a placebo (plain water) mouth rinse

Timeline

• Start date: 2021-07-21
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2020-12-09
• Last updated: 2025-07-08
• Results posted: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study