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Quantitative Evaluation of Aerosols Produced in the Dental Office

Primary Purpose

Aerosol Disease, Caries,Dental

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Caries treatment with a dental turbine
Caries treatment with Er:YAG laser
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aerosol Disease focused on measuring laser, Er:YAG, disinfection, bacteria, high-volume evacuator

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - The subjects were chosen for the study under the subsequent inclusion criteria: occurrence of medium or profound caries on Black class I, ICDAS 3,4 Exclusion Criteria: Patients with systematic diseases that can influence the treatment of periodontitis Patients under or took antibiotics 2 months. Patients under or took immunosuppressors the last 6 months. Pregnant or lactating woman.

Sites / Locations

  • Oral Surgery Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dental turbine

Laser

Arm Description

In the first group, G1 (n=30) a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by a dental turbine.

In the second G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by an Er:YAG laser.

Outcomes

Primary Outcome Measures

Aerosols measurment
The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).
Aerosols measurment
The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).

Secondary Outcome Measures

Bacteriological study
The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
Bacteriological study
The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
Bacteriological study
The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.

Full Information

First Posted
June 28, 2023
Last Updated
August 3, 2023
Sponsor
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05988359
Brief Title
Quantitative Evaluation of Aerosols Produced in the Dental Office
Official Title
Assessment of Aerosol Quantity Generated During Caries Treat-ment With Er:YAG Laser. A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Maintaining biosafety in dental practice requires an efficient elimination of aerosols produced during dental treatment. The objective of this research was to assess the quantity of aerosols and aerobic bacteria present in the air during the treatment of caries. Methods: This study was divided into two groups based on the caries treatment method involving 60 patients with 60 m olar teeth (n=60) in the mandible. Group 1 (n=30) received a conventional dental turbine W&H Synea TA-98LC (W&H, Bürmoos, Austria), while Group 2 (n=30) received an Er:YAG laser (LightWalker, Fotona, Slovenia). Measurements of aerosol particles between 0.3 - 10.0 μm near the operator's mouth were taken using the PC200 laser particle counter (Trotec GmbH, Schwerin, Germany). The number of aerobic bacteria in the air was determined using 60 micro-biological plates with a microbiological medium (Columbia Agar with 5% Sheep Blood) and the sedimentation method. A control group G3 was established to measure the initial aero-sol level and the initial total number of bacteria CFUs (colony-forming units) before each treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aerosol Disease, Caries,Dental
Keywords
laser, Er:YAG, disinfection, bacteria, high-volume evacuator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dental turbine
Arm Type
Active Comparator
Arm Description
In the first group, G1 (n=30) a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by a dental turbine.
Arm Title
Laser
Arm Type
Experimental
Arm Description
In the second G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment by an Er:YAG laser.
Intervention Type
Procedure
Intervention Name(s)
Caries treatment with a dental turbine
Intervention Description
G1 (n=30) conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.
Intervention Type
Procedure
Intervention Name(s)
Caries treatment with Er:YAG laser
Intervention Description
G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.
Primary Outcome Measure Information:
Title
Aerosols measurment
Description
The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).
Time Frame
immediately before the procedure
Title
Aerosols measurment
Description
The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).
Time Frame
immediately after the procedure
Secondary Outcome Measure Information:
Title
Bacteriological study
Description
The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
Time Frame
60 miniutes before the procedure
Title
Bacteriological study
Description
The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
Time Frame
immediately before the procedure
Title
Bacteriological study
Description
The total number of aerobic bacteria in the air of the dental office was carried out by the Koch sedimentation method. The study used 60 Petri dishes with a microbiological medium (Columbia Agar with 5% Sheep Blood) to check the number of aerobic bacteria. Twenty plates were opened 60 minutes before the study (control group, n=20) and closed before the start of caries treatment. Next, forty plates were opened at the start of car-ies treatment with additional using a conventional evacuator (n=20) or a new evacuator (n=20) and closed 60 minutes after the treatment.
Time Frame
immediately after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - The subjects were chosen for the study under the subsequent inclusion criteria: occurrence of medium or profound caries on Black class I, ICDAS 3,4 Exclusion Criteria: Patients with systematic diseases that can influence the treatment of periodontitis Patients under or took antibiotics 2 months. Patients under or took immunosuppressors the last 6 months. Pregnant or lactating woman.
Facility Information:
Facility Name
Oral Surgery Department
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Quantitative Evaluation of Aerosols Produced in the Dental Office

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