MedTrace Logo

Hydrogen Peroxide Fumigation in Dental Office Environment

NCT06100848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-25

No results posted yet for this study

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

Interventions

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.

DIAGNOSTIC_TEST

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)

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2023-05-01
Completion
2023-09-25

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100848 on ClinicalTrials.gov