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The subject of this thesis study is the effects of SWEEPS laser and ultrasonic activation methods on the immune response in the treatment of apical periodontitis in healthy individuals and patients with Type 2 diabetes requiring retreatment, based on a comparative investigation of Toll-like Receptor 9 (TLR-9), Interleukin-6 (IL-6) and Tumour Necrosis Factor alpha (TNF-α), and Interleukin-10 (IL-10) levels.
Patients included in the study will be randomly assigned to two main groups using www.randomizer.org. DOS samples will be collected in both the control and experimental groups during both sessions. A total of 90 patients will be divided into two main groups: systemically healthy individuals (n=45) and patients with type 2 diabetes (n=45). Each main group will be divided into three subgroups (n=15) according to the irrigation protocol applied: conventional irrigation, ultrasonic activation (16) and SWEEPS laser activation (17) will not be applied, and periapical exudate samples will be taken from all patients in both sessions. GROUP 1- Healthy patients Group 1A - Conventional irrigation Group 1B - Ultrasonic activation Group 1C - SWEEPS laser activation GROUP 2 - Patients with type 2 diabetes Group 2A - Conventional irrigation Group 2B - Ultrasonic activation Group 2C - SWEEPS laser activation After collecting DOS samples from the relevant teeth, patients will be administered local anaesthesia with 1.8 ml articaine HCl (Ultracain DS Forte; Pharma Vision San. Ve Tic. A.Ş. Istanbul, Turkey) containing 1:100,000 epinephrine, and the teeth will be isolated using a rubber dam. After disinfecting the crowns of the relevant teeth with 2.5% NaOCl, the caries and existing restorations will be removed, and the access cavity will be disinfected with 2.5% NaOCl. After determining the root canal orifices, Protaper Universal Retreatment (Dentsply Mallefer, Ballagues, Switzerland) will be used for root canal filling removal. (18) Subsequently, the working length will be determined using an electronic apex locator (Ai-Pex, Woodpecker Medical Instrument Co., Guilin, China) and confirmed with a periapical radiograph. For the canal shaping procedure, Eighteeth (Changzhou Sifary Medical Technology Co., Ltd., China) endodontic motor and Protaper Gold (Dentsply Sirona, Charlotte, NC, USA) nickel-titanium rotary files, using the crown-down technique, up to #F5. After each file change, the root canal will be irrigated with 2 mL of 2.5% NaOCl. After the root canal enlargement procedure is completed, the following solutions will be applied for final irrigation: 10 mL of 2.5% NaOCl, 10 mL of 0.5% sodium thiosulphate, 5 mL of distilled water, 5 mL of 17% EDTA, and 5 mL of serum. After the sample collection process is completed, ELISA analysis will be performed using commercial kits to measure TNF-α, IL-6, IL-10, and TLR-9 levels. The analysis of the samples will be carried out at the Laboratory of the Scientific and Technological Research Application and Research Centre at Kırıkkale University. ELISA analysis methods will be performed according to the manufacturer's application instructions.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Kirikkale University Faculty of Dentistry
Kırıkkale, Kırıkkale, Turkey (Türkiye)
Start Date
January 28, 2026
Primary Completion Date
June 30, 2026
Completion Date
May 15, 2027
Last Updated
February 10, 2026
90
ESTIMATED participants
Lead Sponsor
bengisu yüksel
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06671587