Evaluation of Aerosol in a Dental Clinic

Phase 4

Completed

• Conditions: Covid19
• Interventions: Device: High volume evacuation (HVE); Drug: Hydrogen Peroxide; Device: Extraoral vacuum aspirator (EVA); Drug: Placebo

• Registration Number: NCT04659928
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-09
• Study Start: 2021-07-21
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Status Verified: 2025-06
• Results First Submitted: 2025-06-18
• Results First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Results First Posted: 2025-07-08
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• prepping natural teeth at the appointment
• at least an hour long procedure
• procedure will be the first one in the morning

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High volume evacuation (HVE) suction only and hydrogen peroxide	High volume evacuation (HVE)	-
High volume evacuation (HVE) suction only and hydrogen peroxide	Hydrogen Peroxide	-
HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide	High volume evacuation (HVE)	-
HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide	Extraoral vacuum aspirator (EVA)	-
HVE suction and extraoral vacuum aspirator (EVA) and hydrogen peroxide	Hydrogen Peroxide	-
HVE suction and extraoral vacuum aspirator (EVA) and Placebo	High volume evacuation (HVE)	-
HVE suction and extraoral vacuum aspirator (EVA) and Placebo	Extraoral vacuum aspirator (EVA)	-
HVE suction and extraoral vacuum aspirator (EVA) and Placebo	Placebo	-
High volume evacuation (HVE) suction only and Placebo	High volume evacuation (HVE)	-
High volume evacuation (HVE) suction only and Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Bacterial Colony Forming Units (CFUs)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Bacterial Colony Forming Units (CFUs) at Each Location	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 number of Bacterial CFUs per location is reported.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States