Apical PeriodontitisNCT07504861
Biomarkers in Apical Periodontitis
A study testing laser activation, PUI and CSI in people with Apical Periodontitis and Retreatment, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Retreatment, Biomarkers
- What is being tested?
- laser activation, PUI and CSI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University, Faculty of Dentistry
Kirikkale, Kırıkkale, 71100
About this study
Official title: Effects of Different Irrigation Activation Techniques on Pro-inflammatory Cytokine and Proteolytic Enzyme Levels in Teeth With Chronic Apical Periodontitis
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Apical Periodontitis, Retreatment, Biomarkers, Cytokine
- Being tested
- laser activation, PUI, CSI
- Keywords
- Apical periodontitis, SWEEPS, Ultrasonic activation, Cytokines, MMP-9, Endodontics
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser activationOther
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.
PUIOther
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.
CSIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SWEEPS Group | Experimental | 22 participants. Method: Retreatment using SWEEPS activation. Collection of PAE samples. Receives: Other: laser activation |
| US Group | Experimental | 22 participants. Method: Retreatment using US activation. Collection of PAE samples. Receives: Other: PUI |
| CSI Group | Other | 22 participants. Method: Retreatment using CSI activation. Collection of PAE samples. Receives: Other: CSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 7. days
Secondary 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.
Measured: Baseline and 7.days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start30 Aug 2026
- Primary completion17 Oct 2026
- Study completion17 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Durust Baris, Kırıkkale University
- Investigators
- Sevda DURUST BARIS, Asst. Prof., Principal investigator, Kirikkale University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504861
- Sponsor's protocol ID
- 2025/14-2025.10.17
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Irrigation Activation Techniques on Pro-inflammatory Cytokine and Proteolytic Enzyme Levels in Teeth With Chronic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07504861
- Acronym / sponsor ID
- 2025/14-2025.10.17
- Conditions
- Apical Periodontitis, Retreatment, Biomarkers, Cytokine
- Keywords
- Apical periodontitis, SWEEPS, Ultrasonic activation, Cytokines, MMP-9, Endodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- 17 Oct 2026 (actual)
- Study completion
- 17 Oct 2026 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SWEEPS Group | Experimental | Other: laser activation22 participants. Method: Retreatment using SWEEPS activation. Collection of PAE samples. |
| US Group | Experimental | Other: PUI22 participants. Method: Retreatment using US activation. Collection of PAE samples. |
| CSI Group | Other | Other: CSI22 participants. Method: Retreatment using CSI activation. Collection of PAE samples. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- Need for antibiotic prophylaxis
- Diabetes
- Hematological disorders
- Use of antibiotics or anti-inflammatory drugs within the last month.
- Excessive plaque and tartar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser activationNaOCl 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. | Other | SWEEPS Group |
| PUINaOCl 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. | Other | US Group |
| CSIIrrigation 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. | Other | CSI Group |
Primary outcome
Change in Proinflammatory Cytokine Levels (TNF-α and IL-1β)
Time frame: Baseline and 7. days
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.
1 secondary outcome
Change in Proteolytic Enzyme Levels (MMP-9)
Time frame: Baseline and 7.days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevda DURUST BARIS, Asst. Prof. principal investigator
Kirikkale University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser activation, PUI and CSI in people with Apical Periodontitis and Retreatment, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proinflammatory Cytokine Levels (TNF-α and IL-1β) (time frame: Baseline and 7. days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.