Endodontic TreatmentNCT06470126
Disinfection Effect of Gaseous Ozone
A study testing 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: The OzonyTronX® interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. and 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. in people with Endodontic Treatment, run by Ankara University.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Treatment
- What is being tested?
- 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: The OzonyTronX® interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. and 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2010to 12 Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Endodontic Treatment
- Being tested
- 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: The OzonyTronX® interventions performed in the study are root- canal therapies and disinfection procedure of these therapies., 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.
- Keywords
- root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5% NaOCl group: The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.Procedure or surgery
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)
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 or surgery
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.
2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 2.5% NaOCl | Active comparator | 2.5% NaOCl was applied as a root canal irrigation agent. Receives: 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. Receives: 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® Receives: Procedure: 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start26 Dec 2010
- Primary completion12 Aug 2012
- Study completion12 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic TreatmentStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The teeth of the participants were randomly divided into three groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Firdevs Tulga Öz, Ankara University
- Investigators
- Firdevs TULGA OZ, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470126
- Sponsor's protocol ID
- 3/6
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disinfection Effect of Gaseous Ozone on Candida Albicans and Enterococcus Faecalis: A Randomized Clinical Trial in Infected Primary Molars
- ClinicalTrials.gov ID
- NCT06470126
- Acronym / sponsor ID
- 3/6
- Conditions
- Endodontic Treatment
- Keywords
- root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 26 Dec 2010 (actual)
- Primary completion
- 12 Aug 2012 (actual)
- Study completion
- 12 Aug 2012 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The teeth of the participants were randomly divided into three groups.
| Arm | Type | Receives |
|---|---|---|
| 2.5% NaOCl | Active comparator | Procedure: 2.5% NaOCl group: The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.2.5% NaOCl was applied as a root canal irrigation agent. |
| 0.9% sterile saline solution combined with 80 seconds OzonyTronX® | Experimental | 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.0.9% sterile saline solution was combined with 80 seconds OzonyTronX® application as a root canal irrigation procedure. |
| 2.5% NaOCl with 80 seconds OzonyTronX® | Experimental | Procedure: 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies.2.5% NaOCl was applied as an intracanal medicament in combination with 80 seconds OzonyTronX® |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | 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.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. | Procedure or surgery | 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.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. | Procedure or surgery | 2.5% NaOCl with 80 seconds OzonyTronX® |
Primary outcome
Values of C. albicans and E. faecalis prior to the application and following the applications
Time frame: 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.
1 secondary outcome
Assessment the change in the amount of C. albicans and E. faecalis in percentage following irrigation/disinfection procedures
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firdevs TULGA OZ study director
Ankara University
Questions about this trial
What is this clinical trial studying?
A study testing 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: The OzonyTronX® interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. and 2.5% NaOCl with 80 seconds OzonyTronX®:The interventions performed in the study are root- canal therapies and disinfection procedure of these therapies. in people with Endodontic Treatment, run by Ankara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of C. albicans and E. faecalis prior to the application and following the applications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.