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临床试验/NCT07443605
NCT07443605已完成不适用

Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease.

University of Trieste1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
cortisol and dehydroepiandrosterone sulfate

研究概览

简要总结

This study was designed with a double-blind observation design on a population of patients with different periodontal conditions.

The aim is to assess the influence of allostatic loading through the dosage of cortisol, DHEA, DHEAS in both periodontitis pathogenesis and non-surgical periodontal treatment.

The NNT will be built on the biases related to the pathologies in existence. The indicative number of patients is around 100 units and samples will be taken at t0 (baseline, dental visit with periodontal evaluation) and t60 (60 days after non-surgical periodontal treatment). For this study there is no randomization of groups, the dental treatments that will be performed will be in the usual clinical practice and will not be in any way influenced by the objectives of the study.

MATERIALS AND METHODS:

At baseline, the periodontal chart will be performed, a SVS (Stress-Related Vulnerability Scale) test questionnaire will be taken and biological markers will be evaluated by taking a small strand of hair. The same revaluations will also be carried out at 60 days.

Patients will also be recruited according to an information system, training and will be given a paper informed consent in accordance with the current legislation which is attached.

The sample once taken will be kept at the health facility until the analysis of the sample and the results will then be communicated to the patient within 30 days.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Periodontitis stages III or IV

排除标准

  • < 18 years or > 70 years pregnant or lactating females Periodontal treatment in the previous 6 months

研究组 & 干预措施

Hair markers levels in stressed periodontal patients

Other

干预措施: stressed periodontal patients (Diagnostic Test)

结局指标

主要结局

cortisol and dehydroepiandrosterone sulfate

时间窗: 3 months

cortisol (pg/mg) and dehydroepiandrosterone Sulfate (pg/mg) present in the hair of periodontal patients

次要结局

未报告次要终点

研究者

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

Bevilacqua Lorenzo

DDS, Msc Clinical Department of Medical Sciences, Surgery and Healt, University of Trieste, Trieste, Italy

University of Trieste

研究点 (1)

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