INVESTIGATION OF THE EFFECT OF DIFFERENT ACTIVATION TECHNIQUES ON TLR9, IL6, IL10, TNF-ALFA LEVELS IN HEALTHY AND TYPE 2 DIABETIC PATIENTS WITH APICAL PERIODONTITIS REQUIRING RETREATMENT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- TLR9 expression levels in periapical exudate and gingival crevicular fluid samples
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the study:
- •Patients aged 18-50 years
- •Patients with ASA I status
- •Patients with Type 2 diabetes whose HbA1c values are between 5.5% and 9.0%, with diabetes diagnosis confirmed by medical history and laboratory tests (HbA1c test)
- •Upper and lower incisors and lower premolars with chronic apical periodontitis,
- •Teeth requiring retreatment with a PAI score ≥3 will be included in the study. (15)
排除标准
- •ASA II or higher,
- •Pregnant women or those suspected of being pregnant,
- •Patients with localized or generalized periodontitis,
- •Patients with inflammatory or autoimmune diseases such as hepatitis, HIV infection, immunosuppressive chemotherapy, bleeding disorders, Behçet's syndrome, and arthritis,
- •Individuals with HbA1c levels above 9%,
- •5. Those who have used antibiotics within the last month and anti-inflammatory drugs within the last week,
- •Patients with periodontal pockets greater than 3 mm in the relevant tooth,
- •Those with internal or external root resorption,
- •Those with swelling, palpation pain, or a fistula in the relevant area,
- •Those with root fracture or incomplete root formation,
- •Teeth that cannot be isolated with a rubber dam will not be included in the study.
- •The name, surname, age, gender, contact information, and tooth number to be treated of patients included in the study will be recorded on the case report form. Periapical radiographs will be taken of the relevant teeth prior to root canal treatment to examine the root canal anatomy. The periapical health status of each tooth will be assessed using the PAI score.
研究组 & 干预措施
healty group
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 , and SWEEPS laser activation . Periapical exudate samples will be collected from all patients in both sessions.
type 2 diabet mellitus group
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 , and SWEEPS laser activation . Periapical exudate samples will be collected from all patients in both sessions.
结局指标
主要结局
TLR9 expression levels in periapical exudate and gingival crevicular fluid samples
时间窗: Immediately after the procedure
TLR9 will be measured in periapical exudate and gingival crevicular fluid (GCF) samples obtained during routine root canal treatment. The analysis will be performed using the ELISA method. The aim is to compare expression levels between healthy individuals and patients with type 2 diabetes mellitus.
次要结局
- Correlation analysis between TLR9, IL6, IL10, and TNF-α levels in periapical exudate and gingival crevicular fluid samples(Immediately after the procedure)
研究者
bengisu yüksel
phd student
Kırıkkale University