Apical PeriodontitisNCT07171762
Effect of Ozone Use in Intracanal Irrigation on Oxidative Stress Level in Teeth With Asymptomatic Apical Periodontitis
A study testing Ozonytron XP and Physiological saline solution (0.9% NaCl) in people with Apical Periodontitis and Oxidative Stress, run by KEZBAN MELTEM ÇOLAK at 1 site in Turkey (Türkiye).
Trial summary
This clinical study aims to investigate the oxidative stress-related effects of ozone irrigation in patients with asymptomatic apical periodontitis undergoing root canal treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apical Periodontitis, Oxidative Stress
- What is being tested?
- Ozonytron XP and Physiological saline solution (0.9% NaCl)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients must be between 18 and 65 years of age 2. Single-rooted, asymptomatic apical periodontitis with necrotic teeth 3. Teeth with periapical lesion size classified as score 3 or 4 according to the Orstavik classification 4. Periapical Assessment Index (PAI) of 2 or higher 5. Patients with ASA I status
Who cannot join
- Teeth with multiple roots
- Patients with ASA II or higher
- Pregnant women or those suspected of being pregnant
- Patients with a history of allergies
- Teeth with excessive material loss where a rubber dam cannot be applied
- Teeth with root fractures or an open apex
Show all 10Show fewer
- Teeth that have previously undergone root canal treatment
- Presence of canal curvature greater than Schilder 25°,
- Patients with generalized periodontitis,
- Presence of a periodontal pocket greater than 3mm in the relevant tooth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
ATATURK UNIVERSITY, FACULTY of DENTISTRY, Department of ENDODONTICS
Erzurum, Erzurum, 25240
About this study
Official title: A Randomized Controlled Trial Comparing Intracanal Ozone Therapy and Conventional Irrigation on Oxidative Stress in Asymptomatic Apical Periodontitis
This clinical study aims to investigate the oxidative stress-related effects of ozone irrigation in patients with asymptomatic apical periodontitis undergoing root canal treatment. A total of 60 patients who meet the inclusion criteria will be randomly assigned into two groups using an online randomization tool: an ozone irrigation group and a saline irrigation (control) group. The primary objective is to assess the biochemical effects of ozone therapy on oxidative stress markers in periapical interstitial fluid, including but not limited to TAS, TOS, MDA, and 8-OHdG, by using ELISA kits.
After routine canal preparation and initial irrigation protocol (NaOCl-EDTA-NaOCl), baseline periapical fluid samples will be collected using standardized sterile paper points. Following this, experimental irrigation will be applied: ozone water in the study group and saline solution in the control group. Second periapical fluid samples will be collected immediately after this procedure. Subsequently, calcium hydroxide dressing will be placed into the canals, and the patients will be recalled after one week. At the second visit, after removal of the intracanal medicament, a third sample will be collected from each patient.
Ethical approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Atatürk University Faculty of Medicine. The results of this study are expected to contribute to the understanding of ozone therapy as a biocompatible and effective disinfection agent in endodontic procedures and to provide insights into its role in modulating oxidative stress within the periapical environment.
Read the detailed description
This randomized controlled clinical trial investigates the effect of ozone irrigation on oxidative stress levels in teeth diagnosed with asymptomatic apical periodontitis. Apical periodontitis, characterized by inflammation of periapical tissues in response to persistent root canal infection, often progresses silently and can affect long-term endodontic success. In recent years, ozone therapy has gained attention due to its strong antimicrobial, anti-inflammatory, and tissue-regenerative properties. This study evaluates whether ozone irrigation during endodontic treatment can modulate oxidative stress biomarkers more effectively than traditional saline irrigation.
Study Objective
The primary aim is to compare oxidative stress marker levels (TAS, TOS, MDA, and 8-OHdG) in periapical fluid samples following ozone versus saline irrigation
. Study Design and Participants
A total of 60 patients aged between 18-65, each diagnosed with a single-rooted tooth exhibiting asymptomatic apical periodontitis, were included based on strict inclusion/exclusion criteria. Patients with systemic disease, recent antibiotic use, or periodontal involvement were excluded. Randomization was conducted via [www.randomizer.org](http://www.randomizer.org) to allocate participants into two groups (n=30 each):
Group A: Ozone irrigation group Group B: Saline (control) irrigation group
Each patient provided written informed consent, and the study received ethical approval from the Atatürk University Non-Interventional Clinical Research Ethics Committee (Decision No: B.30.2.ATA.0.01.00/557, Date: 27.09.2024).
Endodontic Procedure and Sampling Phases
After local anesthesia (2% articaine with 1:100,000 epinephrine) and rubber dam isolation, standardized root canal preparation was performed using rotary NiTi systems. During shaping, 2.5% NaOCl was used for initial irrigation. Final irrigation protocol common to both groups involved:
- 5 mL of 2.5% NaOCl
- 5 mL of 17% EDTA
- 5 mL of 2.5% NaOCl again
All irrigations were performed using 30-gauge side-vented needles.
Periapical Fluid Sampling Points
Sampling was done using sterile paper points inserted 2 mm beyond the apex, each held for 1 minute, and repeated with 3 paper points per canal. Each sample was stored in PBS-filled, coded Eppendorf tubes at -80°C.
Sample 1 (Baseline):
Collected immediately after final irrigation.
Sample 2 (After group-specific irrigation):
Group A received 5 mL of ozone water irrigation. Group B received 5 mL of sterile saline irrigation.
Samples were collected again using the same protocol.
Sample 3 (Post-medication):
Calcium hydroxide was placed as intracanal medicament. Patients were recalled after 7 days, Ca(OH)₂ was removed, and a third sample was obtained.
Laboratory Analysis
All samples were stored at -80°C until biochemical analysis. The oxidative stress markers were quantified using commercial ELISA kits according to manufacturer protocols.
Outcome Measures
Change in oxidative stress levels (TAS, TOS, MDA, 8-OHdG) at three time points.
Significance of the Study
This is the first known randomized clinical trial to assess the influence of ozone irrigation on oxidative stress biomarkers in periapical fluid. Given the potential of oxidative stress to affect tissue healing and inflammation, understanding the biochemical impact of ozone could offer novel insight into improving endodontic outcomes, especially in cases where apical healing is critical.
- Conditions
- Apical Periodontitis, Oxidative Stress
- Being tested
- Ozonytron XP, Physiological saline solution (0.9% NaCl)
- Keywords
- Ozone Therapy, Endodontics, Oxidative Stress, Apical Periodontitis, Intracanal Irrigation, Antioxidant Status, Oxidant Status, Malondialdehyde (MDA), 8-Hydroxydeoxyguanosine (8-OHdG)
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonytron XPDevice
This intervention involves the use of ozonated water as a final irrigation solution during root canal treatment in teeth diagnosed with asymptomatic apical periodontitis. Following standard chemomechanical preparation, ozonated water is delivered into the root canal system using a 30-gauge side-vented needle. The aim is to assess the biochemical changes in periapical tissues by evaluating oxidative stress markers (TAS, TOS, MDA, 8-OHdG) in the apical fluid samples collected before and after irrigation. The ozonated water is generated via a medical-grade ozone generator, and its application is designed to minimize cytotoxicity while maximizing antimicrobial and oxidative stress modulation properties. The outcomes are compared to a control group receiving saline irrigation under identical procedural conditions.
Physiological saline solution (0.9% NaCl)Other
Physiological saline solution (0.9% NaCl) was used as the final irrigation agent in root canal treatment.Saline Irrigation Group (Control)
| Study group | Role | What they receive |
|---|---|---|
| Ozone Irrigation Group | Experimental | Participants in this arm will undergo root canal irrigation using ozonated water instead of conventional irrigants. Ozonated water is generated using a medical ozone generator (Ozonytron XP) and applied passively into the canal space. The aim is to evaluate its effect on oxidative stress markers such as TAS, TOS, MDA, and 8-OHdG in periapical fluid collected before and after irrigation. The irrigation protocol includes passive delivery with 30G side-vented needles following initial canal shaping. No sodium hypochlorite or EDTA is used in this group. This arm is designed to assess the biological impact of ozonated water as an alternative disinfection protocol in asymptomatic apical periodontitis. Receives: Device: Ozonytron XP |
| Saline Irrigation Group (Control) | Active comparator | Participants in this group will receive conventional root canal irrigation using sterile saline (0.9% NaCl) solution. This irrigation is delivered passively into the canal space after instrumentation, using 30G side-vented irrigation needles. No active chemical disinfectant such as NaOCl or EDTA is used in this arm. Periapical fluid samples will be collected before and after irrigation, and analyzed for oxidative stress markers (TAS, TOS, MDA, and 8-OHdG). This group serves as a control to compare the biological effects of ozonated water irrigation in asymptomatic apical periodontitis cases Receives: Other: Physiological saline solution (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxidative stress biomarkers in periapical fluid following ozone or saline irrigation
The primary outcome is the quantitative change in oxidative stress markers including Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Malondialdehyde (MDA), and 8-Hydroxy-2'-deoxyguanosine (8-OHdG) in periapical fluid. Measurements are taken at three time points:
Immediately after canal preparation and final irrigation (ozonated water or saline), After application of the irrigant (ozonated water in the test group, saline in the control group), One week later, following the removal of calcium hydroxide medication. Samples are collected using sterile paper points and analyzed using ELISA and Western blot techniques. The purpose is to evaluate the antioxidant and oxidative stress responses to ozonated water compared to saline.
Measured: From baseline to 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start27 Sep 2024
- Primary completion20 Oct 2024
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- 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
- Participants were randomly assigned to one of two parallel groups. The experimental group received ozone irrigation and the control group received saline irrigation during endodontic treatment. Oxidative stress markers were analyzed at multiple time points.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KEZBAN MELTEM ÇOLAK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, KEZBAN MELTEM ÇOLAK, Ataturk University
- Investigators
- Kezban Meltem Çolak, Prof.Dr., Principal investigator, ATATURK UNIVERSITY, FACULTY of DENTISTRY, Department of ENDODONTICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171762
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/557
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azarpazhooh A, Limeback H. The application of ozone in dentistry: a systematic review of literature. J Dent. 2008 Feb;36(2):104-16. doi: 10.1016/j.jdent.2007.11.008. Epub 2007 Dec 31.
PubMed 18166260Kazancioglu HO, Kurklu E, Ezirganli S. Effects of ozone therapy on pain, swelling, and trismus following third molar surgery. Int J Oral Maxillofac Surg. 2014 May;43(5):644-8. doi: 10.1016/j.ijom.2013.11.006. Epub 2013 Dec 11.
PubMed 24332588Nagayoshi M, Fukuizumi T, Kitamura C, Yano J, Terashita M, Nishihara T. Efficacy of ozone on survival and permeability of oral microorganisms. Oral Microbiol Immunol. 2004 Aug;19(4):240-6. doi: 10.1111/j.1399-302X.2004.00146.x.
PubMed 15209994
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Intracanal Ozone Therapy and Conventional Irrigation on Oxidative Stress in Asymptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07171762
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/557
- Conditions
- Apical Periodontitis, Oxidative Stress
- Keywords
- Ozone Therapy, Endodontics, Oxidative Stress, Apical Periodontitis, Intracanal Irrigation, Antioxidant Status, Oxidant Status, Malondialdehyde (MDA)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KEZBAN MELTEM ÇOLAKUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Sep 2025 (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.
This clinical study aims to investigate the oxidative stress-related effects of ozone irrigation in patients with asymptomatic apical periodontitis undergoing root canal treatment. A total of 60 patients who meet the inclusion criteria will be randomly assigned into two groups using an online randomization tool: an ozone irrigation group and a saline irrigation (control) group. The primary objective is to assess the biochemical effects of ozone therapy on oxidative stress markers in periapical interstitial fluid, including but not limited to TAS, TOS, MDA, and 8-OHdG, by using ELISA kits.
After routine canal preparation and initial irrigation protocol (NaOCl-EDTA-NaOCl), baseline periapical fluid samples will be collected using standardized sterile paper points. Following this, experimental irrigation will be applied: ozone water in the study group and saline solution in the control group. Second periapical fluid samples will be collected immediately after this procedure. Subsequently, calcium hydroxide dressing will be placed into the canals, and the patients will be recalled after one week. At the second visit, after removal of the intracanal medicament, a third sample will be collected from each patient.
Ethical approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Atatürk University Faculty of Medicine. The results of this study are expected to contribute to the understanding of ozone therapy as a biocompatible and effective disinfection agent in endodontic procedures and to provide insights into its role in modulating oxidative stress within the periapical environment.
Detailed description
This randomized controlled clinical trial investigates the effect of ozone irrigation on oxidative stress levels in teeth diagnosed with asymptomatic apical periodontitis. Apical periodontitis, characterized by inflammation of periapical tissues in response to persistent root canal infection, often progresses silently and can affect long-term endodontic success. In recent years, ozone therapy has gained attention due to its strong antimicrobial, anti-inflammatory, and tissue-regenerative properties. This study evaluates whether ozone irrigation during endodontic treatment can modulate oxidative stress biomarkers more effectively than traditional saline irrigation.
Study Objective
The primary aim is to compare oxidative stress marker levels (TAS, TOS, MDA, and 8-OHdG) in periapical fluid samples following ozone versus saline irrigation
. Study Design and Participants
A total of 60 patients aged between 18-65, each diagnosed with a single-rooted tooth exhibiting asymptomatic apical periodontitis, were included based on strict inclusion/exclusion criteria. Patients with systemic disease, recent antibiotic use, or periodontal involvement were excluded. Randomization was conducted via [www.randomizer.org](http://www.randomizer.org) to allocate participants into two groups (n=30 each):
Group A: Ozone irrigation group Group B: Saline (control) irrigation group
Each patient provided written informed consent, and the study received ethical approval from the Atatürk University Non-Interventional Clinical Research Ethics Committee (Decision No: B.30.2.ATA.0.01.00/557, Date: 27.09.2024).
Endodontic Procedure and Sampling Phases
After local anesthesia (2% articaine with 1:100,000 epinephrine) and rubber dam isolation, standardized root canal preparation was performed using rotary NiTi systems. During shaping, 2.5% NaOCl was used for initial irrigation. Final irrigation protocol common to both groups involved:
- 5 mL of 2.5% NaOCl
- 5 mL of 17% EDTA
- 5 mL of 2.5% NaOCl again
All irrigations were performed using 30-gauge side-vented needles.
Periapical Fluid Sampling Points
Sampling was done using sterile paper points inserted 2 mm beyond the apex, each held for 1 minute, and repeated with 3 paper points per canal. Each sample was stored in PBS-filled, coded Eppendorf tubes at -80°C.
Sample 1 (Baseline):
Collected immediately after final irrigation.
Sample 2 (After group-specific irrigation):
Group A received 5 mL of ozone water irrigation. Group B received 5 mL of sterile saline irrigation.
Samples were collected again using the same protocol.
Sample 3 (Post-medication):
Calcium hydroxide was placed as intracanal medicament. Patients were recalled after 7 days, Ca(OH)₂ was removed, and a third sample was obtained.
Laboratory Analysis
All samples were stored at -80°C until biochemical analysis. The oxidative stress markers were quantified using commercial ELISA kits according to manufacturer protocols.
Outcome Measures
Change in oxidative stress levels (TAS, TOS, MDA, 8-OHdG) at three time points.
Significance of the Study
This is the first known randomized clinical trial to assess the influence of ozone irrigation on oxidative stress biomarkers in periapical fluid. Given the potential of oxidative stress to affect tissue healing and inflammation, understanding the biochemical impact of ozone could offer novel insight into improving endodontic outcomes, especially in cases where apical healing is critical.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups. The experimental group received ozone irrigation and the control group received saline irrigation during endodontic treatment. Oxidative stress markers were analyzed at multiple time points.
| Arm | Type | Receives |
|---|---|---|
| Ozone Irrigation Group | Experimental | Device: Ozonytron XPParticipants in this arm will undergo root canal irrigation using ozonated water instead of conventional irrigants. Ozonated water is generated using a medical ozone generator (Ozonytron XP) and applied passively into the canal space. The aim is to evaluate its effect on oxidative stress markers such as TAS, TOS, MDA, and 8-OHdG in periapical fluid collected before and after irrigation. The irrigation protocol includes passive delivery with 30G side-vented needles following initial canal shaping. No sodium hypochlorite or EDTA is used in this group. This arm is designed to assess the biological impact of ozonated water as an alternative disinfection protocol in asymptomatic apical periodontitis. |
| Saline Irrigation Group (Control) | Active comparator | Other: Physiological saline solution (0.9% NaCl)Participants in this group will receive conventional root canal irrigation using sterile saline (0.9% NaCl) solution. This irrigation is delivered passively into the canal space after instrumentation, using 30G side-vented irrigation needles. No active chemical disinfectant such as NaOCl or EDTA is used in this arm. Periapical fluid samples will be collected before and after irrigation, and analyzed for oxidative stress markers (TAS, TOS, MDA, and 8-OHdG). This group serves as a control to compare the biological effects of ozonated water irrigation in asymptomatic apical periodontitis cases |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients must be between 18 and 65 years of age 2. Single-rooted, asymptomatic apical periodontitis with necrotic teeth 3. Teeth with periapical lesion size classified as score 3 or 4 according to the Orstavik classification 4. Periapical Assessment Index (PAI) of 2 or higher 5. Patients with ASA I status
Key exclusion criteria (10 listed)
- Teeth with multiple roots
- Patients with ASA II or higher
- Pregnant women or those suspected of being pregnant
- Patients with a history of allergies
- Teeth with excessive material loss where a rubber dam cannot be applied
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 |
|---|---|---|
| Ozonytron XPThis intervention involves the use of ozonated water as a final irrigation solution during root canal treatment in teeth diagnosed with asymptomatic apical periodontitis. Following standard chemomechanical preparation, ozonated water is delivered into the root canal system using a 30-gauge side-vented needle. The aim is to assess the biochemical changes in periapical tissues by evaluating oxidative stress markers (TAS, TOS, MDA, 8-OHdG) in the apical fluid samples collected before and after irrigation. The ozonated water is generated via a medical-grade ozone generator, and its application is designed to minimize cytotoxicity while maximizing antimicrobial and oxidative stress modulation properties. The outcomes are compared to a control group receiving saline irrigation under identical procedural conditions. | Device | Ozone Irrigation Group |
| Physiological saline solution (0.9% NaCl)Physiological saline solution (0.9% NaCl) was used as the final irrigation agent in root canal treatment.Saline Irrigation Group (Control) | Other | Saline Irrigation Group (Control) |
Primary outcome
Change in oxidative stress biomarkers in periapical fluid following ozone or saline irrigation
Time frame: From baseline to 7 days after treatment
The primary outcome is the quantitative change in oxidative stress markers including Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Malondialdehyde (MDA), and 8-Hydroxy-2'-deoxyguanosine (8-OHdG) in periapical fluid. Measurements are taken at three time points: Immediately after canal preparation and final irrigation (ozonated water or saline), After application of the irrigant (ozonated water in the test group, saline in the control group), One week later, following the removal of calcium hydroxide medication. Samples are collected using sterile paper points and analyzed using ELISA and Western blot techniques. The purpose is to evaluate the antioxidant and oxidative stress responses to ozonated water compared to saline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 18166260Azarpazhooh A, Limeback H. The application of ozone in dentistry: a systematic review of literature. J Dent. 2008 Feb;36(2):104-16. doi: 10.1016/j.jdent.2007.11.008. Epub 2007 Dec 31.
- Results publication: PubMed 24332588Kazancioglu HO, Kurklu E, Ezirganli S. Effects of ozone therapy on pain, swelling, and trismus following third molar surgery. Int J Oral Maxillofac Surg. 2014 May;43(5):644-8. doi: 10.1016/j.ijom.2013.11.006. Epub 2013 Dec 11.
- Results publication: PubMed 15209994Nagayoshi M, Fukuizumi T, Kitamura C, Yano J, Terashita M, Nishihara T. Efficacy of ozone on survival and permeability of oral microorganisms. Oral Microbiol Immunol. 2004 Aug;19(4):240-6. doi: 10.1111/j.1399-302X.2004.00146.x.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Kezban Meltem Çolak, Prof.Dr. principal investigator
ATATURK UNIVERSITY, FACULTY of DENTISTRY, Department of ENDODONTICS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozonytron XP and Physiological saline solution (0.9% NaCl) in people with Apical Periodontitis and Oxidative Stress, run by KEZBAN MELTEM ÇOLAK at 1 site in Turkey (Türkiye).
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 1 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in oxidative stress biomarkers in periapical fluid following ozone or saline irrigation (time frame: From baseline to 7 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07171762, which also lists 3 linked publications.
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 18 Sep 2025.