Disinfection Effect of Gaseous Ozone

NCT06470126 | Completed DMC

• 1 other identifier: 3/6
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endodontic Treatment

Keywords

root canal treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment the change in the amount of C. albicans and E. faecalis in percentage following irrigation/disinfection procedures

  6 months

Study Arms (3)

2.5% NaOCl

ACTIVE COMPARATOR

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.

0.9% sterile saline solution combined with 80 seconds OzonyTronX®

EXPERIMENTAL

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.

2.5% NaOCl with 80 seconds OzonyTronX®

EXPERIMENTAL

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.

Interventions

2.5% NaOCl group: The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. PROCEDURE

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)

2.5% NaOCl

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

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.

0.9% sterile saline solution combined with 80 seconds OzonyTronX®

2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. PROCEDURE

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.

2.5% NaOCl with 80 seconds OzonyTronX®

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Officials

• Firdevs TULGA OZ

  Ankara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The groups were randomly divided by investigator.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Model Details: The teeth of the participants were randomly divided into three groups.

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 24, 2024
• Study Start: December 26, 2010
• Primary Completion: August 12, 2012
• Study Completion: August 12, 2012
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share