An interventional study of laser activation and PUI in Apical Periodontitis, Retreatment and Biomarkers, sponsored by Kırıkkale University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Kırıkkale University · Not applicable, Interventional, and Treatment
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Among 80 studies in Periapical Periodontitis with a site in Turkey — 13 open to participants now, 20 under way, none of them phase 3. Periapical Periodontitis · Turkey.
Among the 80 studies in Periapical Periodontitis with a site in Turkey, this one is the 37th largest by enrollment of the 74 interventional ones that give a count, is one of 10 that started in 2026, is one of 72 with no phase, and was the 64th registered.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
Browse Periapical Periodontitis studies →13 of the 80 studies in Periapical Periodontitis with a site in Turkey are open now. Recruiting first, the newest first:
Karadeniz Technical University · Sites in Turkey
Ages 18–65
Alanya Alaaddin Keykubat University · Sites in Turkey
Ages 18–70
Medipol University · Sites in Turkey
Ages 18–65 · Healthy volunteers
Mustafa Kemal University · Sites in Turkey
Ages 18–60 · Healthy volunteers
ESRA DAĞCI · Sites in Turkey
Ages 18+ · Healthy volunteers
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 43 Periapical Periodontitis studies recruiting now, 17 (40%) set no upper age limit and 25 (58%) stop at 75 or younger; 5 take children under 18; 21 take healthy volunteers.
This study: 18 Years to 35 Years · male · healthy volunteers too.
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80 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 10 started in 2026.
This study's enrollment of 66 is close to the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Median enrollment 65 across the 74 interventional studies, 60 across the 6 observational. Of the 59 that completed or were terminated, 1 (2%) have results posted.
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1 of 80 have an industry lead sponsor. The 10 most frequent:
Kırıkkale University is the lead sponsor of 114 studies on the registry; 24 are open to participants now.
Kırıkkale University has 3 studies filed under Periapical Periodontitis — fewer than ten, so there is no comparison to draw.
7 of the studies in Periapical Periodontitis with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07867314Recep Tayyip Erdogan UniversityEffect of Apical Patency on Periapical Lesion Healing | 2026-11-27 |
| NCT07850895Recep Tayyip Erdogan UniversityEffects of Irrigation Activation Methods on Periapical Healing in Chronic Apical Periodontitis | 2026-12 |
| NCT07921277Karadeniz Technical UniversityEffects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis | 2026-12-30 |
| NCT07714733Alanya Alaaddin Keykubat UniversityEffect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment | 2027-03-15 |
| NCT07353008Mustafa Kemal UniversityEffect of Different Chelation Protocols on the Healing of Periapical Lesions in Teeth With Chronic Apical Periodontitis | 2027-04 |
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Among the 80 studies in Periapical Periodontitis with a site in Turkey, from their registry updates:
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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.
The sample size was calculated using G*Power v3.1 (Heinrich Heine University, Düsseldorf). Based on a significance level of 0.05 and a power of 0.90, it was determined that 18 samples per group were sufficient. Accounting for potential dropouts, a total of 66 patients are planned for inclusion.
Inclusion Criteria:
Male patients aged 18-35.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 (\<1 cm) with an Orstavik PAI score of 3 or 4.Ethical compliance will be ensured through informed consent; patients will be briefed on the study, and those willing to participate will sign a voluntary informed consent form. Patient demographics (name, age, gender), contact information, tooth number, and clinical symptoms/findings will be recorded in case report forms (CRF).
Exclusion Criteria:
Patients requiring antibiotic prophylaxis, those with diabetes or hematological diseases, or those who have used antibiotics/anti-inflammatory drugs within the last month. Pregnant patients, teeth with heavy plaque/calculus, gingival redness/bleeding, severe gingivitis, generalized periodontitis, or periodontal pocket depths >3 mm. Teeth with sinus tracts, internal/external resorption, swelling, or pain on palpation will also be excluded. Treatment Protocol Local anesthesia [1.8 mL 4% articaine HCl with 1:100,000 epinephrine (Ultracain DS Forte)] will be administered. Teeth will be isolated using a rubber dam (OpalDam, Ultradent). Asepsis will be maintained using 30% H₂O₂ and 2.5% NaOCl (Werax). Following access cavity preparation, the coronal third of the gutta-percha will be removed using #3 and #4 Gates Glidden drills. All procedures will be performed under high magnification using a dental operating microscope (Carl Zeiss Meditec AG).Working length (WL) will be determined with an electronic apex locator (Morita Root ZX Mini). Canal instrumentation will be completed using Reciproc R25 and R50 files (VDW) at WL. If gutta-percha remnants are radiographically visible, additional preparation will be performed with large-sized hand K-files. Canals will be irrigated with 2 mL of 2.5% NaOCl after each file change using a 30-gauge side-vented needle (NaviTip). Recapitulation will be performed to maintain apical patency.To inactivate NaOCl, 0.5% sodium thiosulfate will be used, followed by 5 mL of saline. Patients will be randomly assigned to three final irrigation groups (n=22 per group) using an online randomizer (www.randomizer.org). Conventional Syringe Irrigation (CSI): 10 mL of 2.5% NaOCl and 10 mL %17 EDTA using a 30G needle placed 1 mm short of WL. Ultrasonic Irrigation Activation (UI): 10 mL of 2.5% NaOCl and 10 ML %17 EDTA applied using an ultrasonic device (EMS miniPiezon) and a K-file tip (#25) at 50% power with up-and-down motions for 20 second cycles. SWEEPS (Shock Wave Enhanced Emission Photoacoustic Streaming): Er:YAG laser (LightWalker AT, Fotona) at 2940 nm, 50 μs pulse duration, H14 handpiece, SWEEPS mode (0.3 W, 15 Hz, 20 mJ). A 600 μm fiber tip (600/9) will be held stationary in the access cavity while 10 mL of 2.5% NaOCl and 10 mL %17 EDTA is activated in four 20-second cycles.Following the first session, calcium hydroxide medication will be applied, and the access cavity will be sealed with sterile Teflon tape and zinc phosphate cement. One week later, at the second session, isolation and asepsis will be repeated, and second periapical exudate (PAE) samples will be collected before completing the root canal treatment and permanent composite resin restoration.
Periapical Sampling Procedure: On days 0 and 7, sampling will be performed using #20 sterile paper points placed 2 mm beyond the apical foramen for 60 seconds. The apical 4 mm of the paper point will be cut with sterile scissors and placed into a sterile Eppendorf tube. This process will be repeated three times.ELISA Analysis Samples stored at -80°C will be thawed and 300 μL of Dulbecco's Phosphate Buffered Saline (DPBS, pH 7.2) will be added to each tube. Samples will be vortexed at 25 Hz for 1 minute. Tissue homogenization will be performed using an ultrasonic homogenizer (Sonics Vibra-cell) for 1 minute, followed by centrifugation at 5000 rpm for 5 minutes at +4°C. TNF-α, IL-1β, and MMP-9 levels will be measured using ELISA kits at 450 nm absorbance.
Statistical Analysis Data will be analyzed using IBM SPSS Statistics v20. Linear regression analysis will identify factors (treatment group, gender, tooth number, age) influencing the percentage change in biomarkers. If data are not normally distributed, the Wilcoxon test will be used for pre- vs. post-treatment comparisons, and the Kruskal-Wallis test for inter-group comparisons. Age distribution will be analyzed via Kruskal-Wallis, and gender/tooth distribution via the Chi-square test. Significance is set at (p \< 0.05).
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Exclusion Criteria:
22 participants. Method: Retreatment using SWEEPS activation. Collection of PAE samples.
Other: laser activation
22 participants. Method: Retreatment using US activation. Collection of PAE samples.
Other: PUI
22 participants. Method: Retreatment using CSI activation. Collection of PAE samples.
Other: CSI
NaOCl and EDTA were each delivered in four 2.5-mL portions, with each portion delivered continuously during a 20-s laser activation cycle, resulting in a total activation time of 80 s per irrigant. Activation was performed using a 2940-nm Er laser (LightWalker AT; Fotona, Ljubljana, Slovenia) equipped with an H14 handpiece and a SWEEPS tip measuring 600 μm in diameter and 9 mm in length (SWEEPS 600/9; Fotona). The laser was operated in SWEEPS mode at 20 mJ, 15 Hz, and 0.3 W, with the water and air spray functions switched off. The tip was positioned in the access cavity and maintained stationary throughout activation. Between NaOCl and EDTA application, 5 mL of saline was delivered using a 30-gauge NaviTip needle without laser activation.
NaOCl and EDTA were each delivered in four 2.5-mL portions, with each portion delivered continuously during a 20-s ultrasonic activation cycle, resulting in a total activation time of 80 s per irrigant. Activation was performed using an ultrasonic unit (miniPiezon; EMS, Nyon, Switzerland) and a 25/25 ultrasonic tip (IF43727; Satelec, Acteon, Mérignac, France) operated at 50% power. The tip was positioned 1 mm short of the working length at its deepest insertion and moved vertically over a 4-5 mm amplitude without binding to the canal walls. Between NaOCl and EDTA application, 5 mL of saline was delivered using a 30-gauge NaviTip needle without ultrasonic activation.
Irrigation was performed sequentially with 10 mL of 2.5% NaOCl, 5 mL of saline, and 10 mL of 17% EDTA using a 30-gauge NaviTip needle positioned 1 mm short of the working length. NaOCl and EDTA were each delivered in four 2.5-mL portions, each administered over 20 s, resulting in a total irrigation time of 80 s per irrigant.
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. days
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.days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2026 to primary completion in Oct 2026, 1 month.
Of 171 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's 1 month is below that.
Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
Completion moved once since we started tracking on Sep 25, 2026: Nov 2026 → Oct 2026, on Oct 21, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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