The Effect of Vitamin D Levels and Supplementation on Anti-inflammatory Response in Periodontal Disease: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 4: Stage III-IV periodontitis with vitamin D deficiency
干预措施: Non-surgical periodontal treatment (Procedure)
Group 4: Stage III-IV periodontitis with vitamin D deficiency
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
Group 5: Chronic gingivitis with vitamin D deficiency
干预措施: Non-surgical periodontal treatment (Procedure)
Group 5: Chronic gingivitis with vitamin D deficiency
干预措施: Vitamin D administration (Dietary Supplement)
Group 5: Chronic gingivitis with vitamin D deficiency
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
Group 6: Chronic gingivitis with vitamin D deficiency
干预措施: Non-surgical periodontal treatment (Procedure)
Group 6: Chronic gingivitis with vitamin D deficiency
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
Group 7: Periodontally healthy group with sufficient vitamin D levels
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
Group 8: Periodontally healthy group with vitamin D deficiency
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
Group 3: Stage III-IV periodontitis with vitamin D deficiency
干预措施: Non-surgical periodontal treatment (Procedure)
Group 3: Stage III-IV periodontitis with vitamin D deficiency
干预措施: Vitamin D administration (Dietary Supplement)
Group 2: Stage I-II periodontitis group with vitamin D deficiency
干预措施: Non-surgical periodontal treatment (Procedure)
Group 2: Stage I-II periodontitis group with vitamin D deficiency
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
Group 3: Stage III-IV periodontitis with vitamin D deficiency
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
Group 1: Stage I-II periodontitis group with vitamin D deficiency
干预措施: Non-surgical periodontal treatment (Procedure)
Group 1: Stage I-II periodontitis group with vitamin D deficiency
干预措施: Vitamin D administration (Dietary Supplement)
Group 1: Stage I-II periodontitis group with vitamin D deficiency
干预措施: Oral Hygiene Education and Patient Motivation (Procedure)
研究者
Hatice Yemenoğlu
Doctor
Recep Tayyip Erdogan University Training and Research Hospital