Hydrogen Peroxide Fumigation in Dental Office Environment

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06100848
• Other study ID #: WroclawMU5
• Status: Completed
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: September 25, 2023

Study information

• Verified date: October 2023
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 25, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aerosol Disease
• Bacterial Infections
• Dental Caries

Intervention

Diagnostic Test:
• Microbiological analysis after Caries treatment
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
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)

Locations

Country	Name	City	State
Poland	Oral Surgery Department	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 / (pr² × 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
Primary	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 / (pr² × 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