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临床试验/NCT04141033
NCT04141033已完成不适用

Assessment of Salivary and Gingival Crevicular Fluid Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis Following Nonsurgical Periodontal Therapy (A Clinical and Biochemical Study)

Ain Shams University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
assess salivary and gingival crevicular fluid neopterin levels in patients with chronic periodontitis in pre- and post-menopausal women

研究概览

简要总结

Neopterin is an early and valuable biomarker of cellular immunity, shown to be a sensitive assessment parameter for cell-mediated immune reactions. Hence determination of neopterin concentrations in distinctive body fluids is of diagnostic interest in a wide range of T lymphocytes and macrophages originated diseases. Increased neopterin production is also found in infections due to intracellular living bacteria and parasites. Neopterin concentration is directly proportional to the reactive oxygen species levels and is inversely related to the serum concentration of antioxidants like alpha-tocopherol. Hence it can be regarded as a marker of reactive oxygen species formed by the activated cellular immune system. Consequentially this is useful for predicting the prognosis and diagnosis of severe form of periodontal diseases. Menopause accomplishes a wide range of changes in women's body, and the oral cavity is also not exceptional. As exalted levels of ovarian hormones, detected in pregnancy and oral contraceptive usage, can lead to an increase of gingival inflammation. On the contrary, menopause shows depleted levels of ovarian sex steroids, which also causes worsening of gingival health. Post-menopause was found to be more aggressive and destructive in nature compared to pre-menopause. It has been assessed that the prevalence of oral discomfort was found to be significantly higher along with low flow rates of the saliva with the presence of periodontal disease more frequently. Studies demonstrated that non-surgical periodontal therapy reduces inflammation and improves periodontal status. Therefore it can be assumed that overall inflammatory markers also reduce after non-surgical periodontal therapy.

详细描述

A total of 30 patients will be selected, 15 per-menopause and 15 post-menopausal women. Full mouth scaling and root planing will be performed. All clinical parameters will be recorded at the baseline visit before mechanical debridement and after 3 months of treatment. Saliva samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Gingival crevicular fluid (GCF) samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Neopterin will be measured in the samples using commercially available Enzyme Linked Immunosorbent Assay (ELISA) kit. Statistical analysis will be performed to the results.

研究设计

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

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged from (35- 60).
  • Clinically diagnosed with chronic moderate periodontitis having more than 10 natural teeth and at least two teeth exhibiting clinical attachment loss (CAL) ≥4 mm.
  • Systemically healthy individuals and not taking any hormonal therapy or drugs that affect hormonal status.
  • Patient compliance

排除标准

  • Pregnant or lactating females.
  • Periodontal treatment <6 months prior to the preliminary visit.

结局指标

主要结局

assess salivary and gingival crevicular fluid neopterin levels in patients with chronic periodontitis in pre- and post-menopausal women

时间窗: 3 months

measuring of neopterin levels using commercially available ELISA kit

次要结局

  • evaluate the value of neopterin as a biomarker(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abeer Alaa El-Din

Master student at Ain Shams University Faculty of Dentistry

Ain Shams University

研究点 (2)

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