Oxidative StressNCT07059481
Effect of Different Root Canal Sealers on Oxidative Stress Markers
A study testing Root Canal Treatment and Sample Collection and PAI Score Comparasion in people with Oxidative Stress and Chronic Apical Periodontitis, run by bengi gülgü at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to primary purpose investigate and compare oxidative stress markers in patients with chronic apical periodontitis treated with different root canal paste in a single session. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Chronic Apical Periodontitis
- What is being tested?
- Root Canal Treatment and Sample Collection and PAI Score Comparasion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2024to 13 Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy, ASA1 patients,
- Phase 1 periodontal treatment was performed,
- Diagnosed with chronic apical periodontitis in a single tooth with 2 or more roots in the mouth,
- The lesion measured <2 cm on radiographic evaluation,
- The vitality of the tooth was checked by EPT (Ai-Pex, Woodpecker, China) and Cold test (Cerkamed, Poland) and confirmed to be devitalised,
- Socioculturally able to participate in the treatment,
- Individuals who did not smoke or drink alcohol
Who cannot join
- Patients who have used antibiotics in the last three months and analgesics in the last two weeks
- Patients who smoke and/or abuse alcohol
- Patients younger than 18 years or older than 45 years,
- Patients with controlled or uncontrolled systemic disease and life-threatening conditions (ASA 2,3,4,5,6)
- Pregnant or lactating women,
- Patients with poor oral hygiene,
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- Patients who had head and neck radiotherapy,
- With obesity,
- Active periodontal disease,
- Periodontal pocket depth over 3mm,
- There is enough loss of material in the relevant tooth to prevent adequate isolation or to require post placement,
- Clinical examination of the relevant tooth showing symptoms in percussion-palpation,
- Radiographically, the lesion is seen in relation to anatomical formations such as the mandibular canal and maxillary sinus,
- Patients who required prophylactic antibiotic use before invasive dental procedures were excluded from the study.
- Patients who did not attend the follow-up appointment and patients who experienced complications during expansion (instrument seperation, perforation, etc.) were excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ordu University
Ordu, Ordu- Altınordu, 52200
Bengi Gülgü, +905330262002, bengigulgu@gmail.com
Bengi Gülgü
About this study
Official title: Evaluation of Oxidative Stress in Patients With Chronic Apical Periodontitis Treated With Single Session Root Canal Treatment Using Different Root Canal Sealers: in Vivo Study
The goal of this clinical trial is to primary purpose investigate and compare oxidative stress markers in patients with chronic apical periodontitis treated with different root canal paste in a single session. The main questions it aims to answer are:
Is there a change in oxidative stress markers measured from saliva after root canal treatment? Is there a difference between the change of oxidative stress markers in patients using different root canal sealers after root canal treatment?
Read more
Researchers will compare bioceramic-based and epoxy resin-based root canal sealers to see if there are significant differences in oxidative stress markers measured from patients' saliva after root canal treatment.
- Participants will be informed about all procedures before starting the clinical process.
- Participants are expected to allow saliva sampling two times: first sample will be collected on root canal treatment session and second sample will be collected on the 30th day after root canal treatment.
- Participants will be informed in writing about the treatment procedure before starting the clinical process.
- Participants are expected to sign the informed consent form on a voluntary basis.
- Conditions
- Oxidative Stress, Chronic Apical Periodontitis
- Being tested
- Root Canal Treatment and Sample Collection, PAI Score Comparasion
- Keywords
- oxidative stress, root canal sealers, chronic apical periodontitis, periapical index, total oxidant status, total antioxidant status, oxidative stress index, 8-epi, malondialdehyde, myeloperoxidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal Treatment and Sample CollectionOther
Also called Saliva Sample Collection (two times per patient), Sample Collection from Endodontium while root canal treatment session., Completion of root canal obturation with epoxyamine (Itena Obturys) or bioceramic-based sealer (Itena, MTA Bioseal)
Single session root canal treatment procedure will be performed with VDW Gold Reciproc device and reciprocal files (Endo T-Must, Dentac, Turkey). Endodontium Samples will be collected from each patient's root canal, with 15 Hedström files (Dentsplay).
PAI Score ComparasionDiagnostic test
PAI scores of the patients will be determined with periapical films taken before treatment and compared with oxidative stress markers before and after treatment for the epoxyamine group and bioceramic group.
| Study group | Role | What they receive |
|---|---|---|
| 1- Bioceramic Group | Experimental | Patients which had been used bioceramic-based sealer (MTA Bioseal, Itena, France) while root canal treatment. Receives: Other: Root Canal Treatment and Sample Collection; Diagnostic Test: PAI Score Comparasion |
| 2- Epoxy amine Group | Experimental | Patients which had been used epoxyamine resin-based sealer (Itena Obturys, Itena, France) while root canal treatment. Receives: Other: Root Canal Treatment and Sample Collection; Diagnostic Test: PAI Score Comparasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in biochemically measured oxidative stress markers at 30th day in patients treated with epoxyamine/bioceramic root canal pastes.
oxidative stress markers (myeloperoxidase, 8-epi, total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde) will be measured and compared biochemically in saliva samples taken from the patients on the first and thirtieth day.
Measured: three month aproximately
Comparison of the changes observed in biochemically measured oxidative stress markers of patients in the bioceramic group and patients in the epoxyamine group at day 1 and day 30
results of oxidative stress measurement obtained from bioceramic group and epoxyamin group will be compared. comparsion will be performed with biochemical kits for saliva samples.
Measured: three month aproximately
Secondary outcomes (1)
Investigation of the relationship between biochemically measured oxidative stress markers from endodontium and initial saliva samples obtained from all patients and PAI score determined by periapical films
results of PAI and oxidative stress markers measured with biochemical kits will be compromised.
Measured: three months aproximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start18 Mar 2024
- Primary completion2 Sep 2025 (estimated)
- Study completion13 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the results obtained from the groups will be compared and correlated both within and between the groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bengi gülgü
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, bengi gülgü, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059481
- Sponsor's protocol ID
- 2024/53
- Status last verified
- Jul 2025
- First submitted
- 19 Jan 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxidative Stress in Patients With Chronic Apical Periodontitis Treated With Single Session Root Canal Treatment Using Different Root Canal Sealers: in Vivo Study
- ClinicalTrials.gov ID
- NCT07059481
- Acronym / sponsor ID
- 2024/53
- Conditions
- Oxidative Stress, Chronic Apical Periodontitis
- Keywords
- oxidative stress, root canal sealers, chronic apical periodontitis, periapical index, total oxidant status, total antioxidant status, oxidative stress index, 8-epi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- bengi gülgüUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 13 Nov 2025 (estimated)
- First posted
- 10 Jul 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.
The goal of this clinical trial is to primary purpose investigate and compare oxidative stress markers in patients with chronic apical periodontitis treated with different root canal paste in a single session. The main questions it aims to answer are:
Is there a change in oxidative stress markers measured from saliva after root canal treatment? Is there a difference between the change of oxidative stress markers in patients using different root canal sealers after root canal treatment?
Researchers will compare bioceramic-based and epoxy resin-based root canal sealers to see if there are significant differences in oxidative stress markers measured from patients' saliva after root canal treatment.
- Participants will be informed about all procedures before starting the clinical process.
- Participants are expected to allow saliva sampling two times: first sample will be collected on root canal treatment session and second sample will be collected on the 30th day after root canal treatment.
- Participants will be informed in writing about the treatment procedure before starting the clinical process.
- Participants are expected to sign the informed consent form on a voluntary basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- the results obtained from the groups will be compared and correlated both within and between the groups.
| Arm | Type | Receives |
|---|---|---|
| 1- Bioceramic Group | Experimental | Other: Root Canal Treatment and Sample Collection, Diagnostic Test: PAI Score ComparasionPatients which had been used bioceramic-based sealer (MTA Bioseal, Itena, France) while root canal treatment. |
| 2- Epoxy amine Group | Experimental | Other: Root Canal Treatment and Sample Collection, Diagnostic Test: PAI Score ComparasionPatients which had been used epoxyamine resin-based sealer (Itena Obturys, Itena, France) while root canal treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Systemically healthy, ASA1 patients,
- Phase 1 periodontal treatment was performed,
- Diagnosed with chronic apical periodontitis in a single tooth with 2 or more roots in the mouth,
- The lesion measured <2 cm on radiographic evaluation,
- The vitality of the tooth was checked by EPT (Ai-Pex, Woodpecker, China) and Cold test (Cerkamed, Poland) and confirmed to be devitalised,
Key exclusion criteria (15 listed)
- Patients who have used antibiotics in the last three months and analgesics in the last two weeks
- Patients who smoke and/or abuse alcohol
- Patients younger than 18 years or older than 45 years,
- Patients with controlled or uncontrolled systemic disease and life-threatening conditions (ASA 2,3,4,5,6)
- Pregnant or lactating women,
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 |
|---|---|---|
| Root Canal Treatment and Sample CollectionAlso: Saliva Sample Collection (two times per patient), Sample Collection from Endodontium while root canal treatment session., Completion of root canal obturation with epoxyamine (Itena Obturys) or bioceramic-based sealer (Itena, MTA Bioseal)Single session root canal treatment procedure will be performed with VDW Gold Reciproc device and reciprocal files (Endo T-Must, Dentac, Turkey). Endodontium Samples will be collected from each patient's root canal, with 15 Hedström files (Dentsplay). | Other | 1- Bioceramic Group, 2- Epoxy amine Group |
| PAI Score ComparasionPAI scores of the patients will be determined with periapical films taken before treatment and compared with oxidative stress markers before and after treatment for the epoxyamine group and bioceramic group. | Diagnostic test | 1- Bioceramic Group, 2- Epoxy amine Group |
Primary outcome
Changes in biochemically measured oxidative stress markers at 30th day in patients treated with epoxyamine/bioceramic root canal pastes.
Time frame: three month aproximately
oxidative stress markers (myeloperoxidase, 8-epi, total oxidant status, total antioxidant status, oxidative stress index, malondialdehyde) will be measured and compared biochemically in saliva samples taken from the patients on the first and thirtieth day.
Comparison of the changes observed in biochemically measured oxidative stress markers of patients in the bioceramic group and patients in the epoxyamine group at day 1 and day 30
Time frame: three month aproximately
results of oxidative stress measurement obtained from bioceramic group and epoxyamin group will be compared. comparsion will be performed with biochemical kits for saliva samples.
1 secondary outcome
Investigation of the relationship between biochemically measured oxidative stress markers from endodontium and initial saliva samples obtained from all patients and PAI score determined by periapical films
Time frame: three months aproximately
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 10 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root Canal Treatment and Sample Collection and PAI Score Comparasion in people with Oxidative Stress and Chronic Apical Periodontitis, run by bengi gülgü 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 10 Jul 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?
Contact Bengi Gülgü (+905330262002, bengigulgu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in biochemically measured oxidative stress markers at 30th day in patients treated with epoxyamine/bioceramic root canal pastes. (time frame: three month aproximately). The study lists 2 primary outcomes in all. 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 10 Jul 2025.