Clinical trial NCT06470126: Disinfection Effect of Gaseous Ozone
Official title: Disinfection Effect of Gaseous Ozone on Candida Albicans and Enterococcus Faecalis: A Randomized Clinical Trial in Infected Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Treatment
Keywords: root canal treatment
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The teeth of the participants were randomly divided into three groups.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Values of C. albicans and E. faecalis prior to the application and following the applications
timeFrame: 6 months
Secondary outcomes:
measure: Assessment the change in the amount of C. albicans and E. faecalis in percentage following irrigation/disinfection procedures
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: Firdevs TULGA OZ
role: STUDY_DIRECTOR
References: