Hydrogen Peroxide Fumigation in Dental Office Environment

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.

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Key information

Conditions

Bacterial Infections Aerosol Disease Bacterial Infections and Mycoses Dental Caries Infections Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Surgery Department

Wroclaw, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiological analysis after Caries treatment

Diagnostic Test

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.

Microbiological analysis after Caries treatment and fumigation

Diagnostic Test

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 outcomes

Number of bacteria after caries treatment

Time frame: After 48 hours of incubation

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

Time frame: After 48 hours of incubation

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.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

The Impact of Hydrogen Peroxide (H₂O₂) Fumigation on Bacterial Level in Dental Office Environment: A Clinical Trial Investigation

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Oct 25, 2023
Registry last updated: Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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