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Clinical Trials in Turkey / NCT07504861
Starting soon Observational

Biomarkers in Apical Periodontitis

NCT07504861 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-08-30
Last updated
2026-09-15

Condition(s) studied

Apical PeriodontitisRetreatmentBiomarkersCytokine

Study summary

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

Sex
MALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. * Periapical Index (PAI) score of 3 or 4 according to Orstavik classification. Exclusion Criteria: * Need for antibiotic prophylaxis * Diabetes * Hematological disorders * Use of antibiotics or anti-inflammatory drugs within the last month. * Excessive plaque and tartar * Gum redness or bleeding * Severe gingivitis * Widespread periodontitis * Periodontal pocket depths exceeding 3 mm. * Presence of sinus fistula (bleeding). * Presence of internal or external root resorption. * Pain on palpation of teeth * Swelling * Pregnancy during treatment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kırıkkale University, Faculty of Dentistry Kirikkale Kırıkkale

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07504861 on ClinicalTrials.gov ↗ ← All trials in Turkey