Evaluation of Salivary Asprosin, IL-39,IL-40 and IL-1β Levels in Diabetic Patients with Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- measurement of preoperative periodontal parameters
研究概览
简要总结
The aim of this study is to determine the relationships between asprosin, IL-39, IL-40 and IL-1β in saliva between individuals with and without diabetes and between individuals with periodontitis and healthy individuals and to determine the potential roles of these biomarkers that are multiplied in periodontal disease. The study aims to evaluate whether these biomarkers can be used for periodontal diagnosis or prognosis.
The questions answered by the study are as follows:
Do asprosin, IL-39, IL-40 and IL-1β biomarker levels differ between individuals with and without diabetes? Do these biomarker levels differ significantly between individuals with periodontitis and individuals who are healthy? Can these biomarkers be used in the early diagnosis or recording the progression of periodontal diseases?
详细描述
The study is planned to be conducted with 176 individuals with and without periodontal disease between the ages of 18-80 who come to the Department of Periodontics of the Faculty of Dentistry of Necmettin Erbakan University for treatment. Those who sign the 'informed consent form' will be included in the study.
In the periodontal examination of each patient who applies to the periodontology clinic, routine radiographic and clinical evaluations are performed, and routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recessions, body/mass index) are taken and archived before the start of the patients' treatments and after each planned treatment. In addition, the sociodemographic data and brushing habits of each patient who will participate in the study are recorded. Saliva samples will also be collected from patients prior to treatment. Individuals will be divided into groups according to their periodontal disease status:
- 44 periodontally healthy, systemically healthy individuals
- 44 periodontally healthy, type 2 diabetic individuals
- 44 periodontitis, systemically healthy individuals
- 44 periodontitis, type 2 diabetic individuals
A calibrated expert clinician will determine periodontal status according to the criteria of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions based on radiographic and clinical examination. Patients will need to meet the criteria for Stage II and III, generalized, periodontitis to be included in the periodontitis groups.
Saliva samples will be collected before periodontal measurements are taken to prevent saliva from bleeding during probing. Participants will be asked not to brush their teeth at least one hour before the sample collection and to avoid any food, sugary gum, cosmetic products such as lipstick, and any medication that will not affect the salivary hormone measurements. A total of 5 2 ml samples, one for each marker, will be collected from each patient between 9:00 and 10:00 in the morning. The samples will be collected in plastic tubes with a glass funnel within five minutes after each participant rinses their mouth with water. The tubes will then be capped and the samples will be centrifuged at 1000 rpm for 10 minutes to remove cellular elements and plaque. The supernatant liquid will be pipetted without touching the sediment formed at the bottom of the tubes, placed in polypropylene Eppendorf tubes, and stored at -20°C until analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No systemic disease such as nephrotic syndrome, chronic renal disease and cardiovascular disease
- •No dental scaling and root planing treatment in the last 6 months
- •No antibiotic use for any reason
- •Having at least 20 teeth in the mouth
- •Not being pregnant or breastfeeding
- •Inclusion criteria for the periodontally healthy group
- •Having a periodontally healthy diagnosis in routine clinical and radiographic examinations Inclusion criteria for the periodontitis group
- •Diagnosing periodontitis in routine clinical and radiographic examinations
排除标准
- •- Patients with any autoimmune disease (Rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behcet, psoriasis, etc.) - Those who smoke 10 or more cigarettes per day
结局指标
主要结局
measurement of preoperative periodontal parameters
时间窗: before collecting saliva
To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.
gingival index measurement
时间窗: before collecting saliva
The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding). Unit of Measurement: 0-3 scale.
Plaque Index (PI) measurement
时间窗: before collecting saliva
The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.
次要结局
未报告次要终点
研究者
AYSE HUMEYRA ORUC
research assistant
Necmettin Erbakan University