Disinfection Effect of Gaseous Ozone

Not Applicable

Completed

• Conditions: Endodontic Treatment

• Registration Number: NCT06470126
• Lead Sponsor: Ankara University

Brief Summary

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.

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 Timeline

• Study Start: 2010-12-26
• Primary Completion: 2012-08-12
• Study Completion: 2012-08-12
• Status Verified: 2024-06
• Study First Submitted: 2024-06-15
• Study First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Values of C. albicans and E. faecalis prior to the application and following the applications	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Assessment the change in the amount of C. albicans and E. faecalis in percentage following irrigation/disinfection procedures	6 months	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).