EVALUATION OF THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS UNDERGOING BISPHOSPHONATE THERAPY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- salivary levels of IL-17 at 1-month
研究概览
简要总结
Inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels, resulting in increased bone resorption including the jaws. Osteoporosis may have an influence on the periodontal condition of post-menopausal women and the risk for periodontal disease may increase due to osteoporosis. The hypothesis of the study was that non-surgical periodontal treatment and medical treatment of osteoporosis by bisphosphonates may improve the clinical outcomes and decrease salivary levels of IL-1β, IL-17, ALP and 8-OHdG. Therefore, the aim of this study was to evaluate the mechanism of bi-directional relationship between osteoporosis and periodontal diseases and to investigate the outcomes of non-surgical periodontal treatment with regard to salivary levels of IL-1β, IL-17, 8-OHdG and ALP in patients with periodontitis and osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The participants were postmenopausal patients defined as absence of menstruation for at least 12 months.
- •Patients with periodontitis;
- •Patients who had no systemic diseases and were periodontally healthy (no attachment loss),
- •Patients who were treated with oral bisphosphonate at least one year (70 mg tablet once weekly)
排除标准
- •if they had received any periodontal treatment in the preceding three months,
- •if they were pregnant or in the period of lactation,
- •if they had systemic diseases that may interfere with normal healing mechanism,
- •if they had taken antibiotics, anticonvulsants, immunosuppressants, calcium channel blockers in the preceding six months.
结局指标
主要结局
salivary levels of IL-17 at 1-month
时间窗: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 3-month
时间窗: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of IL-17 baseline
时间窗: baseline
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of IL-17 at 3-month
时间窗: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of alkaline phosphatase at 1-month
时间窗: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 1-month
时间窗: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of IL-1β at baseline
时间窗: baseline
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 1-month
时间窗: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 3-month
时间窗: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of alkaline phosphatase at 3-month
时间窗: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of alkaline phosphatase at baseline
时间窗: baseline
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of 8-hydroxydeoxyguanosine at baseline
时间窗: baseline
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
次要结局
- gingival index(baseline, 1- and 3-month follow- up.)
- clinical attachment level(baseline, 1- and 3-month follow- up.)
- Plaque index(baseline, 1- and 3-month follow- up.)
- probing depth(baseline, 1- and 3-month follow- up.)
- bleeding on probing(baseline, 1- and 3-month follow- up.)
研究者
Basak Karasu
Principal Investigator
Gazi University