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Recruiting NCT07059481

Effect of Different Root Canal Sealers on Oxidative Stress Markers

No phase Interventional Oxidative Stress Chronic Apical Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Root Canal Treatment and Sample Collection, PAI Score Comparasion.
Who it may be relevant to
Registry conditions: Oxidative Stress, Chronic Apical Periodontitis. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Root Canal Treatment and Sample Collection
    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).
  • Diagnostic test PAI Score Comparasion
    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 outcome measures

  • Changes in biochemically measured oxidative stress markers at 30th day in patients treated with epoxyamine/bioceramic root canal pastes. [Time frame: 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 [Time frame: three month aproximately]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ordu University — Ordu

Identifiers

NCT: NCT07059481 · 2024/53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗