Investigation of Salivary Ceramide-1-Phosphate and Prostaglandin E2 Levels in Periodontitis Patients With Poorly and Well-Controlled Type 2 Diabetes and Effect of Non-Surgical Periodontal Treatment: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- HbA1c levels
研究概览
简要总结
Diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. With the negative effects of the control of these two diseases, it results in an increase in the severity of diabetes and periodontitis, and they affect many systems together. To elucidate the role of ceramide, which is one of the possible biochemical mechanisms between diabetes and the degree of glycemic control and periodontitis, in inflammation. Aim of this study is the measurement of C1P and PGE2 in saliva and the effect of non-surgical periodontal treatment, which includes the degree of control of diabetes, oral hygiene education, tooth surface cleaning and root surface arrangement, on 3 months.
A total of 102 subjects were included. Clinical periodontal measurements, saliva samples were collected from each individual at baseline and 3 months after non-surgical periodontal treatmet in periodontitis groups. Salivary C1P and PGE2 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 30-65
- •Have not received periodontal treatment in the last 6 months,
- •Does not have any systemic disease and does not use drugs,
- •Not using local or systemic antibiotics in the last 3 months,
- •HbA1c <%7 for the controlled T2DM group,
- •HbA1c ≥7% for the uncontrolled T2DM group,
- •For female patients who are not in the pregnancy or lactation period,
- •Non-smoker,
- •Not regularly using mouthwash/mouthwash.
排除标准
- •Not being willing to participate in the study,
- •Under 30 years old, over 65 years old
- •Having any systemic disease affecting the periodontal condition,
- •To use any medication that may affect the inflammatory process in the last 3 months,
- •Using local or systemic antibiotics in the last 3 months,
- •To have had periodontal treatment in the last 6 months,
- •Being in pregnancy or lactation period for female patients,
- •Using mouthwash regularly
结局指标
主要结局
HbA1c levels
时间窗: baseline to 3 months after treatment
Blood test in routine biochemistry laboratory for evaluation of the change in HbA1c levels of patients with type 2 diabetes from baseline to 3 months after non-surgical periodontal treatment
PGE2 levels in saliva
时间窗: baseline to 3 months after treatment
Change in saliva PGE2 levels from baseline to 3 months after non-surgical periodontal treatment
C1P levels in saliva
时间窗: baseline to 3 months after treatment
Change in saliva C1P levels from baseline to 3 months after non-surgical periodontal treatment
次要结局
- Bleeding on probing index (BOP)(baseline to 3 months after treatment)
- Gingival index (GI)(baseline to 3 months after treatment)
- Probing pocket depth(baseline to 3 months after treatment)
- Clinical attachment level (CAL)(baseline to 3 months after treatment)
- Plaque index (PI)(baseline to 3 months after treatment)
研究者
SELMAN YILMAZ CICEK
Principal Investigator
Ondokuz Mayıs University