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临床试验/NCT03726411
NCT03726411已完成不适用

The Effect of Non-surgical Periodontal Therapy on the Gingival Crevicular Fluid Levels of Prolactin Hormone in Patients With Periodontitis.

Eman Mohamed Amr2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11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
发起方
入组人数
50
试验地点
2
主要终点
prolactin in GCF

研究概览

简要总结

The present study will be conducted on fifty participants. All participants will receive a full-mouth clinical examination, and the following periodontal parameters will be recorded: Plaque Index (PI). Gingival Index (GI), probing depth (PD), and clinical attachment level (CAL). All of these measurements will be recorded at six sites at baseline for all participants and 3 months after non-surgical periodontal therapy for the study group. GCF samples will be collected from the buccal aspects of teeth that had the highest signs of inflammation and attachment loss for periodontitis group at baseline and 3 months after non-surgical periodontal therapy. As for controls, the samples will be collected from buccal aspect of upper first molar at baseline. The samples will be assayed for prolactin by using an enzyme linked immunosorbent assay kits (Elisa) according to the manufacturer instruction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with moderate to severe chronic periodontitis, with probing pocket depth (PPD) ≥ 4-6 mm and clinical attachment level ≥ 4-5 mm, according to the American Academy of Periodontology.7
  • Highly motivated and cooperative patients

排除标准

  • The presence of any systemic disease.
  • Taking medications for the last 3 months before conducting this study.
  • Pregnancy and lactation.
  • Any type of previous periodontal treatment (surgical or non-surgical) in the preceding 6 months.
  • Smoking (former or current).

研究组 & 干预措施

periodontitis group

Experimental

in this group, prolactin in GCF will be assessed at baseline and after 3 months of receiving non-surgical periodontal treatment

干预措施: non-surgical periodontal therapy (Procedure)

control group

No Intervention

in this group of systemically and periodontally healthy participants, prolactin in GCF will be assessed at baseline only

结局指标

主要结局

prolactin in GCF

时间窗: 3 months

prolactin level in GCF by ELISA

次要结局

未报告次要终点

研究者

发起方
Eman Mohamed Amr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eman Mohamed Amr

Associate Professor of Oral Medicine and Periodontology

Cairo University

研究点 (2)

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