Hydrogen Peroxide Fumigation in Dental Office Environment

Sponsor
Wroclaw Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT06100848
Collaborator
(none)
30
1
2
8.7
3.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Microbiological analysis after Caries treatment
  • Diagnostic Test: Microbiological analysis after Caries treatment and fumigation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Impact of Hydrogen Peroxide (H₂O₂) Fumigation on Bacterial Level in Dental Office Environment: A Clinical Trial Investigation
Actual Study Start Date :
Jan 3, 2023
Actual Primary Completion Date :
May 1, 2023
Actual Study Completion Date :
Sep 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Caries treatment

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
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.

Active Comparator: Caries treatment and fumigation

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
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)

Outcome Measures

Primary Outcome Measures

  1. Number of bacteria after caries treatment [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.

  2. Number of bacteria after caries treatment and fumigation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oral Surgery Department Wroclaw Poland

Sponsors and Collaborators

  • Wroclaw Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacek Matys, Principal Investigator, Wroclaw Medical University
ClinicalTrials.gov Identifier:
NCT06100848
Other Study ID Numbers:
  • WroclawMU5
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023