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CompletedNCT05988359Updated Aug 14, 2023

Quantitative Evaluation of Aerosols Produced in the Dental Office

An interventional study of Caries treatment with a dental turbine and Caries treatment with Er:YAG laser in Aerosol Disease and Caries,Dental, sponsored by Wroclaw Medical University. Completed at 1 site in Poland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Wroclaw Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Aug 2021, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aerosol Disease
  • Caries,Dental

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Keywords

  • laser
  • Er:YAG
  • disinfection
  • bacteria
  • high-volume evacuator
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Wroclaw Medical University is the lead sponsor of 93 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureCaries treatment with a dental turbine

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

  • ProcedureCaries 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.

06

What researchers measure

Primary outcomes

  1. Aerosols measurment

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

    Time frame: immediately before the procedure

  2. Aerosols measurment

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

    Time frame: immediately after the procedure

Secondary outcomes

  1. 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.

    Time frame: 60 miniutes before the procedure

  2. 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.

    Time frame: immediately before the procedure

  3. 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.

    Time frame: immediately after the procedure

07

Study locations

1 site
  • Oral Surgery Department
    Wroclaw, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05988359
Lead sponsor
Wroclaw Medical University
Responsible party
Jacek Matys (Principal Investigator, Wroclaw Medical University) — Principal investigator
First posted
Aug 14, 2023
Start date
Aug 28, 2021
Primary completion
Apr 15, 2022
Completion
May 4, 2022
Last update
Aug 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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