Biomarkers in Apical Periodontitis
Effects of Different Irrigation Activation Techniques on Pro-inflammatory Cytokine and Proteolytic Enzyme Levels in Teeth With Chronic Apical Periodontitis
1 other identifier
observational
66
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2026
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedFirst Posted
Study publicly available on registry
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 28, 2026
April 1, 2026
March 1, 2026
4 months
March 18, 2026
March 26, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline and 7. days
Secondary Outcomes (1)
Change in Proteolytic Enzyme Levels (MMP-9)
Baseline and 7.days
Study Arms (3)
SWEEPS Group
22 participants. Method: Retreatment using SWEEPS activation. Collection of PAE samples.
US Group
22 participants. Method: Retreatment using US activation. Collection of PAE samples.
CSI Group
22 participants. Method: Retreatment using CSI activation. Collection of PAE samples.
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kırıkkale University, Faculty of Dentistry
Kırıkkale, Kırıkkale, 71100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sevda DURUST BARIS, Asst. Prof.
Kirikkale University Faculty of Dentistry
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 18, 2026
First Posted
April 1, 2026
Study Start
March 30, 2026
Primary Completion (Estimated)
July 27, 2026
Study Completion (Estimated)
September 28, 2026
Last Updated
April 1, 2026
Record last verified: 2026-03