"Levels of RANKL and OPG in Gingival Crevicular Fluid of Patients With Post-menopausal Osteoporosis / Osteopenia and Periodontal Disease."
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- levels of RANKL and OPG
研究概览
简要总结
The aim of this study was to investigate the levels of RANKL and Osteoprotegerin, and their relationship in gingival crevicular fluid of post-menopausal women with osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that the use of bisphosphonates in periodontal disease.
Study hypothesis:
"The osteoporosis / osteopenia in postmenopausal women patients with periodontal disease affect the ratio RANKL / OPG in gingival crevicular fluid samples favoring osteoclastogenesis processes "
详细描述
81 active periodontal sites from 31 postmenopausal women aged 45-70 years with chronic periodontitis were studied. Samples of gingival crevicular fluid were collected by paper strips and ELISA test was conducted to determine the total concentration of RANKL, OPG, and then obtain the values of the RANKL / OPG ratio. We analyzed 66 samples of gingival crevicular fluid obtained from active periodontal sites of 17 patients with osteopenia / osteoporosis and 15 samples gingival crevicular fluid obtained from active periodontal sites obtained of 14 controls patients with normal osseous condition.
Statistical analyzes were computed and analyzed using Graphpad Software. To determine if the data correspond to a normal distribution the D'Agostino-Pearson test was used. The values of cytokines (RANKL and OPG) and its ratio (RANKL / OPG) were compared using Mann-Whitney Test t U. Analysis Spearman correlation and linear regression for statistic was also performed to determine whether there was any relationship between the variables analyzed. It was considered as statistically significant p value ≤ 0.05.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA).
- •Control group: post-menopausal women with periodontal disease and normal osseous condition.
- •Study group: post-menopausal womens with periodontal disease and osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or ibandronate 150 mg) for longer than 3 months before the study and another.
排除标准
- •Patients with history of aggressive periodontitis and had received any periodontal treatment when they entered the study
- •Patients with any systemic illness (except osteopenia/osteoporosis)
- •Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6 months prior to the study.
结局指标
主要结局
levels of RANKL and OPG
时间窗: one year
次要结局
未报告次要终点
研究者
María Eugenia Verde
María Eugenia Verde - Cátedra de Periodoncia A - UNC
Universidad Nacional de Córdoba