NCT05988359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

June 28, 2023

Last Update Submit

August 3, 2023

Conditions

Aerosol DiseaseCaries,Dental

Keywords

laserEr:YAGdisinfectionbacteriahigh-volume evacuator

Outcome Measures

Primary Outcomes (2)

  • Aerosols measurment

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

    immediately before the procedure

  • Aerosols measurment

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

    immediately after the procedure

Secondary Outcomes (3)

  • Bacteriological study

    60 miniutes before the procedure

  • Bacteriological study

    immediately before the procedure

  • Bacteriological study

    immediately after the procedure

Study Arms (2)

Dental turbine

ACTIVE COMPARATOR

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

Laser

EXPERIMENTAL

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

Caries treatment with a dental turbinePROCEDURE

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

Dental turbine
Caries treatment with Er:YAG laserPROCEDURE

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

Laser

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral Surgery Department

Wroclaw, Poland

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2023

First Posted

August 14, 2023

Study Start

August 28, 2021

Primary Completion

April 15, 2022

Study Completion

May 4, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)