The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases
The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial
A review of the literature revealed that while there are studies investigating the relationship between vitamin D and periodontal disease, there are no studies investigating the anti-inflammatory effect of vitamin D on periodontal disease. Investigators hypothesized that the increased incidence of periodontal disease in individuals with vitamin D deficiency might be due not only to pro-inflammatory effects but also to impaired bone metabolism and a decrease in the anti- inflammatory mechanism. Investigators aimed to determine this by comparing serum and DOS levels of 1,25-dihydroxyvitamin D (1,25(OH)2D), 25-hydroxyvitamin D (25(OH)D3), Receptor activator nuclear kappa B ligand (RANKL), osteoprotegerin (OPG), Tumor Necrosis Factor Related Apoptosis induced Ligand (TRAIL), Developmental endothelial locus (Del)-1, Lipoxin, Resolvin, interleukin (IL)-10, and transforming growth factor-β (TGF-β).
The study will include 120 individuals who are systemically healthy based on clinical and radiographic examinations and diagnosed with Stage I-II periodontitis, Stage III-IV periodontitis, chronic gingivitis, and periodontally healthy. Periodontal clinical parameters (Probing pocket depth (PPD), Clinical attachment level (CAL), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI)) will be recorded three times: before treatment, and 6 and 12 weeks after treatment. Gingival crevicular fluid (GCF) and serum samples will be collected from participants at baseline and 12 weeks later for biochemical analysis.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Hatice Yemenoglu
- 电话号码：+905052977517
- 邮箱：htcymnglu@hotmail.com
学习地点
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Rize、土耳其（türkiye）、53020
- 招聘中
- Recep Tayyip Erdogan University
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接触：
- Hatice Yemenoglu
- 电话号码：+904642220000
- 邮箱：htcymnglu@hotmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Study groups will be formed according to the 2017 Periodontal Disease Classification. Accordingly:
- Periodontally healthy; absence of bleeding on probing, erythema, edema, patient symptoms, attachment, and bone loss
- Gingivitis; patients with an average gingival index ≥0.5 according to Löe and Silness
- Stage I-II periodontitis; patients with CAL 1-2 or 3-4 mm and a maximum PPD ≤5 mm, showing radiographic horizontal bone loss up to the coronal third of the root (15%-33%), but without tooth loss due to periodontitis
- Stage III-IV periodontitis; Stage 3 and 4 patients with ≥15 teeth in their mouth, with CAL ≥5 and PPD ≥6 in at least 6 areas, and radiographic bone loss extending to the middle or apical third of the root.
Exclusion Criteria:
- Individuals who have undergone periodontal treatment in the last 6 months, have systemic diseases (such as diabetes, parathyroid and thyroid-related endocrine diseases) that may affect periodontal status, patients with chronic liver disease, hypoparathyroidism and renal failure, those who have been using medications that may affect periodontal response (aspirin, non-steroidal anti-inflammatory drugs or steroids) for a long time, those who are using additional vitamin D or calcium supplements in the pre-study phase, those who are pregnant or breastfeeding, and those with hypercalcemia and malabsorption syndrome will not be included in the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group 1: Stage I-II periodontitis group with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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实验性的：Group 2: Stage I-II periodontitis group with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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实验性的：Group 3: Stage III-IV periodontitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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实验性的：Group 4: Stage III-IV periodontitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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实验性的：Group 5: Chronic gingivitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants with vitamin D deficiency will receive supplemental vitamin D as recommended by their doctor
Participants will receive oral hygiene education
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实验性的：Group 6: Chronic gingivitis with vitamin D deficiency
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Participants will receive non-surgical periodontal treatment
Participants will receive oral hygiene education
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实验性的：Group 7: Periodontally healthy group with sufficient vitamin D levels
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Participants will receive oral hygiene education
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实验性的：Group 8: Periodontally healthy group with vitamin D deficiency
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Participants will receive oral hygiene education
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Probing pocket depth (PPD)
大体时间：These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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Clinical attachment level (CAL)
大体时间：These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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These parameters will be recorded three times: before treatment, and 6 and 12 weeks after treatment
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Collection of gingival crevicular fluid and serum samples
大体时间：These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
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These parameters were to be recorded 2 times: before treatment and 12 weeks after treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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