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临床试验/NCT07571850
NCT07571850已完成不适用

Gingival Crevicular Fluid Levels of Prolactin Hormone in Obese Patients With Stage ii and Iii Periodontitis Before and After Non-surgical Periodontal Therapy (a Comparative Clinical Study)

Alexandria University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
change in clinical attachment level

研究概览

简要总结

Obesity and periodontitis are among the most common chronic disorders affecting the world population, while Prolactin (PRL) is a neuroendocrine hormone that within the physiological range stimulates bone formation while mild to marked increase in its level induces bone resorption and inhibits bone formation.

Aim of the study: study aims to investigate prolactin (PRL) levels in gingival crevicular fluid (GCF) in obese (O) patients with and without stage II and III periodontitis (P). Further, to evaluate the effect of non-surgical periodontal therapy on these levels compared to controls.

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
25 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Body mass index (more than 29.9 kg/m2).
  • stage II and III periodontitis

排除标准

  • Pregnancy or lactation.
  • Any known systemic disease other than obesity
  • Previous periodontal treatment (surgical or non-surgical) in last 6 months;
  • Antibiotics in the past 3 months.

研究组 & 干预措施

Patients with peridontal disease

Experimental

干预措施: Obese patients with stage II and III periodontitis and non surgical peridontal therapy (Other)

Patients without peridontal disease

Active Comparator

干预措施: obese patients with healthy periodontium with no intervention (Other)

结局指标

主要结局

change in clinical attachment level

时间窗: Baseline and 3 months

Clinical attachment level (CAL) using a Williams probe (which manufactured in Europe from AISI 304 Stainless steel) from a fixed reference point on the crown to the base of the pocket.

change in GCF levels of prolactin hormone

时间窗: Baseline and 3 months

Gingival crevicular fluid sample will be obtained from the buccal aspects of two interproximal sites in teeth that will have the highest signs of inflammation and attachment loss

次要结局

  • change in Probing depth(Baseline and 3 months)
  • change in gingival index(Baseline and 3 months)
  • change in plaque index(Baseline and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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