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NCT Number: NCT07059481

Effect of Different Root Canal Sealers on Oxidative Stress Markers

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, Ordu- Altınordu, 52200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bengi Gülgü

CONTACT

[email protected]

+905330262002

Bengi Gülgü

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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,
  • 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.

Treatment and study plan

Root Canal Treatment and Sample Collection

Other

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 names: 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)

PAI Score Comparasion

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

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

    Time frame: three months aproximately

    results of PAI and oxidative stress markers measured with biochemical kits will be compromised.

Study contacts

Contact information is provided by the study sponsor or research team.

Bengi Gülgü

CONTACT

[email protected]

+905330262002

Sponsors and collaborators

Lead sponsor

bengi gülgü

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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