Biomarkers in Apical Periodontitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-35
SponsorKırıkkale University
About this trial
Aim: To evaluate the effects of three different irrigation activation techniques-conventional syringe irrigation (CSI), ultrasonic irrigation (UI), and SWEEPS (Shock Wave Enhanced Emission Photoacoustic Streaming)-on the levels of proinflammatory cytokines (Tumor Necrosis Factor Alpha (TNF-α), interleukin-1beta (IL-1β)) and proteolytic enzymes matrix metalloproteinase-9 (MMP-9) in teeth with chronic apical periodontitis.
Methodology: Sixty-six male patients (aged 18-35) with single-rooted teeth, previous root canal treatment (at least 4 years ago), and periapical lesions (\<1 cm, PAI score 3 or 4) were included. Sample size was determined by G\*Power (Power=0.90, α=0.05). Following local anesthesia and rubber dam isolation, endodontic access was performed under a dental operating microscope. After removing old filling material and completing root canal preparation with Reciproc R25/R50 files, patients were randomly assigned into three groups (n=22 each): (1) CSI (30G needle), (2) UI (EMS miniPiezon), and (3) SWEEPS (Er:YAG laser, 2940 nm). Periapical exudate samples were collected using sterile paper points (2 mm beyond the apex for 60s) at the first visit (pre-treatment) and the second visit (one week post-medication with calcium hydroxide). Samples were analyzed via ELISA for TNF-α, IL-1β, and MMP-9 levels.
Statistical Analysis: Data were analyzed using IBM SPSS 20. Percent changes in biomarker levels were evaluated using the Kruskal-Wallis test for inter-group comparisons and the Wilcoxon test for intra-group (pre- vs. post-treatment) comparisons. Linear regression was used to identify effective factors (group, age, gender, tooth type). Significance was set at (p \< 0.05).
Keywords: Apical periodontitis, SWEEPS, Ultrasonic activation, Cytokines, MMP-9, Endodontics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male patients aged 18-35 years.
Presence of chronic apical periodontitis in maxillary or mandibular incisors, canines, or single-rooted/single-channeled premolars.
History of root canal treatment performed at least 4 years ago.
Presence of a periapical lesion smaller than 1 cm.
Disqualifiers
Need for antibiotic prophylaxis
Diabetes
Hematological disorders
Use of antibiotics or anti-inflammatory drugs within the last month.
Trial population
The study population consists of male patients aged 18-35 years diagnosed with chronic apical periodontitis in single-rooted teeth with a history of prior root canal treatment and periapical lesions (PAI 3 or 4).
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
66 Participants
are grouped into 3 trial groupsGroup A: SWEEPS Group
Group B: US Group
Group C: CSI Group
Trial outcomes
Primary outcomes
1
Change in Proinflammatory Cytokine Levels (TNF-α and IL-1β)
The primary outcome is the reduction in the levels of proinflammatory cytokines TNF-α and IL-1β in periapical exudate samples, measured by Enzyme-Linked Immunosorbent Assay (ELISA). Results will be expressed in pg/mL or concentration units provided by the ELISA kit to evaluate the effectiveness of the three different irrigation activation techniques (CSI, UI, and SWEEPS) in reducing periapical inflammation.
Time frame
Baseline and 7. daysSecondary outcomes
1
Change in Proteolytic Enzyme Levels (MMP-9)
The secondary outcome is the change in the levels of Matrix Metalloproteinase-9 (MMP-9) in periapical exudate samples, analyzed via ELISA. This measure aims to evaluate the impact of different irrigation protocols on the proteolytic activity associated with tissue destruction in chronic apical periodontitis.
Time frame
Baseline and 7.daysSponsors and contacts
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Source ClinicalTrials.gov
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