Effect of Vitamin D Supplementation in Addition to Non-surgical Periodontal Treatment in Individuals With Type II Diabetes Mellitus and Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Biochemical Data
研究概览
简要总结
This study investigates the clinical and biochemical results of vitamin D supplementation in addition to non-surgical periodontal treatment in individuals with Type II diabetes mellitus and periodontitis.
详细描述
38 individuals with T2DM and periodontitis were included into the study. Clinical periodontal measurements including probing depth, clinical attachment level, plaque and gingival indices were recorded The individuals included in the study were divided into two groups: Individuals given D3K2 with periodontal therapy were included in the test group, and individuals given placebo with periodontal therapy were included in the control group. All serum and gingival crevicular fluid samples from individuals who underwent non-surgical periodontal treatment were taken again at 3rd and 6th months, and clinical periodontal measurements were recorded. Glycated hemoglobin A1c (HbA1c), fasting blood glucose (FBG), 25(OH)D3, parathyroid hormone (PTH), calcium (Ca) and magnesium (Mg) values were determined in serum samples. GCF and serum IL-1ß and IL-10 values were analyzed by enzyme-linked immunosorbent analysis (ELISA).
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, Investigator)
入排标准
- 年龄范围
- 39 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with Stage I-II periodontitis
- •Individuals with HbA1c value ≥6.5 and diagnosed with type 2 DM according to ADA at least 1 year before the study
- •Individuals who do not have a systemic disease other than DM
- •Individuals who do not have systemic complications of diabetes
- •Individuals with 25(OH)D3 value between 20 ng/mL and 30 ng/mL
- •Individuals who are under the control of a doctor for their diabetes
- •Individuals who have not used any antibiotics or long-term anti-inflammatory drugs in the last 6 months
- •Individuals who have not received periodontal treatment in the last 6 months
- •Individuals with BMI value of 18.5 to 30 kg/m2
排除标准
- •Individuals who use alcohol
- •Pregnant or lactating individuals
- •Individuals taking any antioxidant or vitamin supplements
结局指标
主要结局
Biochemical Data
时间窗: At the first 3 and 6th months post treatment for the test and control groups.
HbA1c
Periodontal Clinical Parameters
时间窗: At the 3rd and 6th months post treatment for the test and control groups.
Probing depth, clinical attachment level
次要结局
- Biochemical Data(At the 3rd and 6th months post treatment for the test and control groups.)
研究者
Meltem Karsiyaka Hendek
Assoc. Prof.
Kırıkkale University