Hydrogen Peroxide Fumigation in Dental Office Environment

NCT06100848 | Completed

• 1 other identifier: WroclawMU5
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections; Dental Caries; Aerosol Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  After 48 hours of incubation

• 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.

  After 48 hours of incubation

Study Arms (2)

Caries treatment

ACTIVE COMPARATOR

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.

Diagnostic Test: Microbiological analysis after Caries treatment

Caries treatment and fumigation

ACTIVE COMPARATOR

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.

Diagnostic Test: Microbiological analysis after Caries treatment and fumigation

Interventions

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.

Caries treatment

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)

Caries treatment and fumigation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• use anti-inflammatory medications
• non-smokers
• had systemic illnesses
• with uncompensated diabetes
• with halitosis symptoms
• with gastric diseases

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Oral Surgery Department

Wroclaw, Poland

Location

MeSH Terms

Conditions

Bacterial Infections; Dental Caries

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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: October 12, 2023
• First Posted: October 25, 2023
• Study Start: January 3, 2023
• Primary Completion: May 1, 2023
• Study Completion: September 25, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)