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Hydrogen Peroxide Fumigation in Dental Office Environment

Primary Purpose

Bacterial Infections, Dental Caries, Aerosol Disease

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Microbiological analysis after Caries treatment
Microbiological analysis after Caries treatment and fumigation
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: diagnosed with moderate caries decay based on the International Caries Detection and Assessment System (ICDAS 3 and 4) in their mandibular molar teeth received hygienist treatment two weeks before the study initiation Exclusion Criteria: use anti-inflammatory medications non-smokers had systemic illnesses with uncompensated diabetes with halitosis symptoms with gastric diseases

Sites / Locations

  • Oral Surgery Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Caries treatment

Caries treatment and fumigation

Arm Description

The Koch sedimentation method was used to evaluate the aerobic bacterial content in the dental office air. Thirty plates were opened and then sealed 40 minutes after the initiation of caries treatment.

The Koch sedimentation method was employed to evaluate the aerobic bacterial content in the dental office air. Thirty plates were opened and subsequently sealed 60 minutes after the commencement of caries treatment. Fumigation was conducted for 20 minutes.

Outcomes

Primary Outcome Measures

Number of bacteria after caries treatment
At the onset of caries treatment, thirty plates (n=30) will be opened and will be sealed 40 minutes later. After 48 hours of incubation at 37°C, the degree of microbiological contamination will be determined, calculated as the total number of CFUs (colony-forming units) in one cubic meter of air using the formula: L = a × 1000 / (πr² × k). In the formula, L represents the microbial contamination level in [cfu/m3], 'a' signifies the quantity of bacterial colonies cultivated on the plate, 'r' denotes the Petri dish radius [cm], and 'k' stands for the plate exposure time factor, with k = t × 1/5, where 't' represents the exposure time in minutes.
Number of bacteria after caries treatment and fumigation
Another set of thirty plates (n=30) will be opened immediately before caries treatment and closed 60 minutes later following the completion of fumigation. After 48 hours of incubation at 37°C, the degree of microbiological contamination will be determined, calculated as the total number of CFUs (colony-forming units) in one cubic meter of air using the formula: L = a × 1000 / (πr² × k). In the formula, L represents the microbial contamination level in [cfu/m3], 'a' signifies the quantity of bacterial colonies cultivated on the plate, 'r' denotes the Petri dish radius [cm], and 'k' stands for the plate exposure time factor, with k = t × 1/5, where 't' represents the exposure time in minutes.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2023
Last Updated
October 19, 2023
Sponsor
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06100848
Brief Title
Hydrogen Peroxide Fumigation in Dental Office Environment
Official Title
The Impact of Hydrogen Peroxide (H₂O₂) Fumigation on Bacterial Level in Dental Office Environment: A Clinical Trial Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
September 25, 2023 (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
The study's null hypothesis posits no significant difference in bacterial levels in the dental office environment before and after implementing hydrogen peroxide (H₂O₂) fumigation. The study comprised 30 participants, 18 females and 12 males, all diagnosed with moderate caries decay (ICDAS 3 and 4) in their mandibular molars, averaging 42.2 ± 8.3 years in age. Sample size calculations for 30 microbiological plates in each group utilized G*Power software (Kiel University, Germany), factoring in prior research, with a significance level of 0.05, effect size (d) of 0.72, 95% confidence interval, and 85% power. Aerobic bacterial content in the dental office air was assessed using the Koch sedimentation method. The study employed 60 Petri dishes with Columbia Agar and 5% Sheep Blood. During caries treatment, thirty plates were opened and sealed 40 minutes later, while another set of thirty plates was opened and closed 60 minutes post-fumigation. Measurements were taken 1 meter above the ground and 2 meters from the patient's mouth. After 48 hours of incubation at 37°C, microbiological contamination was calculated as CFUs (colony-forming units) in one cubic meter using the formula: L = a × 1000 / (πr² × k). Fumigation involved a 20-minute treatment with 6% hydrogen peroxide biosanitizer (Saniswiss, Switzerland) via a compressed air device (Fumi-Jet, Kormed, Poland). The process included 3 minutes of fumigation and a 17-minute waiting period for the chemotoxic effect, with 45 ml of 6% hydrogen peroxide sprayed in a 20 m² room.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Dental Caries, Aerosol Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Caries treatment
Arm Type
Active Comparator
Arm Description
The Koch sedimentation method was used to evaluate the aerobic bacterial content in the dental office air. Thirty plates were opened and then sealed 40 minutes after the initiation of caries treatment.
Arm Title
Caries treatment and fumigation
Arm Type
Active Comparator
Arm Description
The Koch sedimentation method was employed to evaluate the aerobic bacterial content in the dental office air. Thirty plates were opened and subsequently sealed 60 minutes after the commencement of caries treatment. Fumigation was conducted for 20 minutes.
Intervention Type
Diagnostic Test
Intervention Name(s)
Microbiological analysis after Caries treatment
Intervention Description
Microbiological analysis was conducted for 30 patients using 30 microbiological plates. These plates were opened simultaneously with the start of the treatment and closed 40 minutes later.
Intervention Type
Diagnostic Test
Intervention Name(s)
Microbiological analysis after Caries treatment and fumigation
Intervention Description
Microbiological analysis was conducted for 30 patients using 30 microbiological plates. These plates were opened simultaneously with the start of the treatment and closed 60 minutes later (when fumigation was finished)
Primary Outcome Measure Information:
Title
Number of bacteria after caries treatment
Description
At the onset of caries treatment, thirty plates (n=30) will be opened and will be sealed 40 minutes later. After 48 hours of incubation at 37°C, the degree of microbiological contamination will be determined, calculated as the total number of CFUs (colony-forming units) in one cubic meter of air using the formula: L = a × 1000 / (πr² × k). In the formula, L represents the microbial contamination level in [cfu/m3], 'a' signifies the quantity of bacterial colonies cultivated on the plate, 'r' denotes the Petri dish radius [cm], and 'k' stands for the plate exposure time factor, with k = t × 1/5, where 't' represents the exposure time in minutes.
Time Frame
After 48 hours of incubation
Title
Number of bacteria after caries treatment and fumigation
Description
Another set of thirty plates (n=30) will be opened immediately before caries treatment and closed 60 minutes later following the completion of fumigation. After 48 hours of incubation at 37°C, the degree of microbiological contamination will be determined, calculated as the total number of CFUs (colony-forming units) in one cubic meter of air using the formula: L = a × 1000 / (πr² × k). In the formula, L represents the microbial contamination level in [cfu/m3], 'a' signifies the quantity of bacterial colonies cultivated on the plate, 'r' denotes the Petri dish radius [cm], and 'k' stands for the plate exposure time factor, with k = t × 1/5, where 't' represents the exposure time in minutes.
Time Frame
After 48 hours of incubation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosed with moderate caries decay based on the International Caries Detection and Assessment System (ICDAS 3 and 4) in their mandibular molar teeth received hygienist treatment two weeks before the study initiation Exclusion Criteria: use anti-inflammatory medications non-smokers had systemic illnesses with uncompensated diabetes with halitosis symptoms with gastric diseases
Facility Information:
Facility Name
Oral Surgery Department
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Hydrogen Peroxide Fumigation in Dental Office Environment

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