Disinfection Effect of Gaseous Ozone

Disinfection Effect of Gaseous Ozone on Candida Albicans and Enterococcus Faecalis: A Randomized Clinical Trial in Infected Primary Molars

The current study aimed to investigate the effect of gaseous ozone in disinfection the root canals of primary teeth. Thirty-six primary molars of 36 completely healthy patients (aged 5-10) were included in the study.The included teeth were randomly divided into three groups as follows:

- sodium hypochlorite applied group, ozone applied group, ozone and sodium hypochlorite applied group.The study hypothesized that the antimicrobial efficiency of gaseous ozone would be higher than the other groups compared.

Study Overview

• Status: Completed
• Conditions: Endodontic Treatment
• Intervention / Treatment: Procedure: 2.5% NaOCl group: The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.; Procedure: 0.9% sterile saline solution combined with 80 seconds: The OzonyTronX® interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.; Procedure: 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.

Detailed Description

The current clinical randomized study's primary purpose was to investigate the antimicrobial efficiency of gaseous ozone on primary teeth root canals.The included teeth were randomly divided into three groups, and in each group, the root canal therapies of 12 primary teeth were done. In the first group, 2.5% sodium hypochlorite was applied as an irrigation agent. In second group, 0.9% sterile saline solution was combined with 80 seconds.

OzonyTronX® application. 2.5% sodium hypochlorite was applied as an intracanal medicament in combination with 80 seconds OzonyTronX® in the last group. Microbial analyses assessed the colonization of Candida albicans and Enterococcus faecalis before and after the procedure.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pediatric patients with no use of an antimicrobial agent in the last 3 months
• Teeth with positive responses to percussion and palpation, no sinus tract and intra-oral, extra-oral swelling,
• Teeth with no pathological and physiological mobility, and restorable with stainless steel crown.
• In radiographical examinations, the selected teeth needed to show the Res(i) and Res (1/4) scores according to the root resorption scoring system
• No radiolucency in the peri-radicular tissue and no internal-external root resorption were also among the including criteria. However, the teeth with lesions only in 1/3 percent of the bifurcation area were also included in the study

Exclusion Criteria:

• Patients who are not compatible with including criteria,
• Who cannot adopt the dental treatments,
• with whom rubber-dam İsolation was not possible were excluded from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2.5% NaOCl; 2.5% NaOCl was applied as a root canal irrigation agent.	Procedure: 2.5% NaOCl group: The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.; 10 mL 2.5% NaOCl application followed the mechanical preparation. After 2 mL 0.9% saline application, the second samples were taken by placing a sterile cone in the largest canal of the tooth (distal canal for 60 seconds). The mesiobuccal and distobuccal canals were closed with a sterile cotton pellet while the samples were taken. After the application, the root canal filling was completed with a calcium hydroxide-containing paste (TgPex™, London, England), glass ionomer cement (Ionofil U, Voco, Cuxhaven, Germany) was placed, and the teeth were restored with a Stainless-Steel Crown (3M ESPE, Seefeld, Germany)
Experimental: 0.9% sterile saline solution combined with 80 seconds OzonyTronX®; 0.9% sterile saline solution was combined with 80 seconds OzonyTronX® application as a root canal irrigation procedure.	Procedure: 0.9% sterile saline solution combined with 80 seconds: The OzonyTronX® interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.; The canals were irrigated with 10 mL 0.9% sterile saline. Ozone treatment (OzonyTronX with CA probe) was applied for 80 seconds, and 2 mL 0.9% saline application was performed. Finally, the second samples were taken by the method described in group with 2.5% NaOCl, and the canal treatment was completed.
Experimental: 2.5% NaOCl with 80 seconds OzonyTronX®; 2.5% NaOCl was applied as an intracanal medicament in combination with 80 seconds OzonyTronX®	Procedure: 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.; The disinfection of root canals was done using 10 mL, 2.5% NaOCl, and ozone treatment for 80 seconds, and 2 mL 0.9% saline application was performed. Finally, the second samples were taken by the method described in group with %2.5 NaOCl, and the canal treatment was completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Values of C. albicans and E. faecalis prior to the application and following the applications	The results of the descriptive statistical analyses of the values of C. albicans and E. faecalis prior to the application and following the applications were shown in Log CFU.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the change in the amount of C. albicans and E. faecalis in percentage following irrigation/disinfection procedures	The Wilcoxon signed-rank test determined the change in the microorganisms in root canals in percentage to compare the effect of irrigation procedures (E. faecalis and C. albicans) (intergroup comparisons-between the groups).	6 months

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Director: Firdevs TULGA OZ, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2010
• Primary Completion (Actual): August 12, 2012
• Study Completion (Actual): August 12, 2012

Study Registration Dates

• First Submitted: June 15, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: root canal treatment
• Other Study ID Numbers: 3/6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO