Quantitative Evaluation of Aerosols Produced in the Dental Office

Sponsor

Wroclaw Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05988359

Collaborator

(none)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aerosol Disease Caries,Dental	Procedure: Caries treatment with a dental turbine Procedure: Caries treatment with Er:YAG laser	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Assessment of Aerosol Quantity Generated During Caries Treat-ment With Er:YAG Laser. A Randomized Clinical Trial.

Actual Study Start Date :

Aug 28, 2021

Actual Primary Completion Date :

Apr 15, 2022

Actual Study Completion Date :

May 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dental turbine 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.	Procedure: Caries treatment with a dental turbine G1 (n=30) conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.
Experimental: Laser 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.	Procedure: Caries treatment with Er:YAG laser G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.

Arm

Intervention/Treatment

Active Comparator: Dental turbine

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.

Procedure: Caries treatment with a dental turbine

G1 (n=30) conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.

Experimental: Laser

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.

Procedure: Caries treatment with Er:YAG laser

G2 (test, n=30) group, a conventional high-volume evacuator (Monoart® Euronda, Vicenza, Italy) was used to remove aerosols during caries treatment.

Outcome Measures

Primary Outcome Measures

Aerosols measurment [immediately before the procedure]
The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).
Aerosols measurment [immediately after the procedure]
The aerosols were measured with a PM200 detector counter (Trotec GmbH, Schwerin, Germany).

Secondary Outcome Measures

Bacteriological study [60 miniutes before the procedure]
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 [immediately before the procedure]
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 [immediately after the procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.