Quantitative Evaluation of Aerosols Produced in the Dental Office

NCT ID: NCT05988359

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-28
• Study Completion Date: 2022-05-04

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.

Conditions

Aerosol Disease; Caries,Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Caries treatment with a dental turbine

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Caries treatment with Er:YAG laser

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jacek Matys

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oral Surgery Department

Wroclaw, , Poland

Countries

Poland

Other Identifiers

WroclawMU4

Identifier Type: -

Identifier Source: org_study_id