Investigation of the Relationship Between Periodontal Disease and Serum and Gingival Crevicular Fluid Sclerostin and Tumor Necrosis Factor- α Levels in Women With Postmenopausal Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum Sample Collection
研究概览
简要总结
Elevated sclerostin levels in serum and alveolar bone of osteoporotic patients may exert deleterious effects on the periodontium, thereby contributing to the progression and increased severity of periodontal disease. Moreover, sclerostin is considered a potential biomarker for elucidating the shared pathophysiological mechanisms linking postmenopausal osteoporosis and periodontitis
详细描述
In this study, it has aimed to reveal the relationship between postmenopausal osteoporosis and periodontitis by comparing inflammatory (TNF-α) and bone destruction biomarker (sclerostin) levels in serum and GCF and clinical periodontal parameters in postmenopausal women with decreased BMD. A total of 80 postmenopausal female have included in our study. Patients have divided into 4 groups according to radiological and clinical examination results as control (Group K), periodontitis (Group P), osteoporosis (Group O) and osteoporosis-periodontitis (Group OP). Clinically, PI, GI, BI, PPD and CAL have measured. TNF-α and sclerostin levels have measured by ELISA method in serum and DOS samples. In addition, L1-L4, femoral total and femoral neck BMD values have determined by DXA method. For statistical analyses, Shapiro Wilk test, Mann Whitney U test, Anova test, Kruskal Wallis test, Post Hoc Bonferroni test, Pearson Chi-Square test, Fisher's Exact test, Pearson and Spearman correlation have used. Results: Serum sclerostin level of Group OP and Group P and GCF sclerostin level of Group OP, Group P and Group O have higher than Group K (p<0.05). A positive correlation has found between serum sclerostin level and serum TNF-α (p=0.013, r=0.278) with GCF TNF-α (p=0.001, r=0.356) levels (p<0.05). A positive correlation has found between GCF TNF-α (p=0.002, r=0.334) and GCF sclerostin level (p<0.05).
The increased level of sclerostin in serum and GCF in osteoporosis patients may increase the severity of periodontal disease by creating a destructive effect on the periodontium; It is also thought that it can be used as a biomarker to elucidate the common mechanism in the relationship between postmenopausal osteoporosis and periodontitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 43 Years 至 78 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged 40 years and older in the postmenopausal period,
- •Individuals diagnosed with osteoporosis or healthy individuals without osteoporosis, as determined by DXA testing of the hip or spine,
- •Individuals who had been postmenopausal for ≥6 months and had not received hormone replacement therapy,
- •Patients who did not smoke or consume alcohol,
- •Female patients who were periodontally healthy or diagnosed with Stage 2-3, Grade A periodontitis
排除标准
- •Patients with chronic renal and hepatic insufficiency; malignant diseases such as diabetes mellitus, leukemia, multiple myeloma, and widespread carcinoma; chronic inflammatory rheumatic diseases such as rheumatoid arthritis and ankylosing spondylitis; and those using drugs that may affect bone metabolism (glucocorticoids, heparin, methotrexate, anticonvulsants),
- •Those who had received antibiotic therapy in the previous 3 months or any medication for osteoporosis treatment,
- •Patients who had undergone surgical or non-surgical periodontal treatment within the previous 6 months,
- •Patients who did not wish to continue participation in the study at the midpoint or at the end of the study.
结局指标
主要结局
Serum Sample Collection
时间窗: 6 month
Venous blood samples will from the left antecubital fossa of the patients
Collection and Quantification of Gingival Crevicular Fluid Samples
时间窗: 6 month
Based on the patient's clinical examination status 24 hours after the periodontal clinical measurements, the deepest probable pocket area for individuals with periodontitis, each in six separate quadrants, will sellect for GCF samples. For periodontally healthy individuals, four teeth with a pocket depth of \<3 mm, a gingival and plaque index of 0, and no bleeding were selected.
次要结局
未报告次要终点
研究者
Mujde Cilkus
Research Assistant
Recep Tayyip Erdogan University