Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin (OPG) and RANKL in Health, Disease and After Treatment
2015年9月28日 更新者：Umut BALLI
The primary objective of this case-control intervention study to explore the effectiveness of non surgical periodontal therapy on the gingival crevicular fluid (GCF) levels of sclerostin in patients with chronic periodontitis (CP) so as to get a more detailed insight into its diagnostic and prognostic potential as a biomarker of periodontal disease.
研究概览
详细说明
All individuals underwent a full-mouth periodontal examination, which included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP).
Individuals were categorized into three groups: individuals with clinically healthy periodontium (group 1), patients with chronic periodontitis (group 2), and group 3 consisted of the patients with chronic periodontitis (group 2), treated by scaling and root planning.
GCF samples in grup 1 were taken at baseline.
In group 2, GCF samples were taken before and after non- surgical periodontal treatment.
Sclerostin, OPG and RANKL levels were determined using the enzyme-linked immunosorbent assay.
研究类型
介入性
注册 (实际的)
54
阶段
- 第一阶段早期
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 49年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Criteria for the healthy group were GI = 0, PPD and CAL ≤ 3 mm, and no signs of attachment and bone loss
- Criteria for the chronic periodontitis group were clinical signs of inflammation, such as red color and swelling of the gingival margin, GI ≥ 2, PPD and CAL ≥ 5 mm with bone loss (>30% of the existing teeth)
Exclusion Criteria:
- Aggressive periodontitis, systemic diseases (i.e., diabetes mellitus, cancer, human immunodeficiency virus, bone-related diseases that compromise sclerostin, OPG or RANKL levels and collagen-metabolic diseases, or disorders), chronic high-dose steroid therapy, radiation or immunosuppressive therapy, allergy or sensitivity to any drug, pregnancy, lactation, and current smoking, smoking within the past 5 years. The individuals had no history of periodontal therapy or drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) for at least six months.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Chronic periodontitis
GCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions) |
|
|
安慰剂比较：clinically healthy periodontium
GCF samples were taken at baseline Intervention: oral hygiene instructions
|
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biochemical parameters (Sclerostin levels, RANKL/OPG ratio )
大体时间：Baseline and 6 weeks after treatment
|
The changes in levels of sclerostin, OPG and RANKL 6 weeks after periodontal treatment determined by ELISA.
The changes in levels of sclerostin were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontal disease.
The relative RANKL/OPG ratio (bone resorption marker) was also calculated to detect the relationship between sclerostin levels.
|
Baseline and 6 weeks after treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
探测口袋深度
大体时间：基线和治疗后 6 周
|
牙周治疗后探诊深度的变化。测量探诊深度以确定疾病的严重程度和临床结果。
|
基线和治疗后 6 周
|
|
菌斑指数
大体时间：基线和治疗后 6 周
|
牙周治疗后菌斑指数的变化。
记录牙菌斑指数以确定和分类口腔卫生状况。
|
基线和治疗后 6 周
|
|
探诊出血
大体时间：基线和治疗后 6 周
|
牙周治疗后探诊出血的变化。
记录探诊出血用于分类和评估（根尖）牙龈炎症。
|
基线和治疗后 6 周
|
|
Probing pocket depth and clinical attachment level
大体时间：Baseline and 6 weeks after treatment
|
The changes in clinical attachment level after periodontal treatment.
Clinical attachment level was measured for determining severity of disease and clinic outcome.
Also, clinical attachment level was also analyzed to detect the relationship between sclerostin, OPG and RANKL levels.
|
Baseline and 6 weeks after treatment
|
|
Gingival index
大体时间：Baseline and 6 weeks after treatment
|
The changes in gingival index after periodontal treatment.
Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.
Also, gingival index was also analyzed to detect the relationship between sclerostin, OPG and RANKL levels.
|
Baseline and 6 weeks after treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年12月1日
初级完成 (实际的)
2014年10月1日
研究完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2015年2月18日
首先提交符合 QC 标准的
2015年3月11日
首次发布 (估计)
2015年3月17日
研究记录更新
最后更新发布 (估计)
2015年9月30日
上次提交的符合 QC 标准的更新
2015年9月28日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.