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Boron Levels, Oxidative Stress, and Inflammation in Periodontitis

2026年8月16日 更新者:Marmara University

Evaluation of the Relationship Between Boron Levels and Oxidative Stress, Antioxidant Defense, and Inflammatory Markers in Individuals With Periodontitis

This cross-sectional observational study aims to evaluate the relationship between boron levels and oxidative stress, antioxidant defense, and inflammatory markers in individuals with periodontitis. The study will include systemically healthy, non-smoking individuals divided into two groups: periodontally healthy controls and patients with Stage III-IV periodontitis. Boron levels and selected oxidative stress, antioxidant, and inflammatory biomarkers will be evaluated in saliva and gingival tissue samples. The findings will be compared between the groups to investigate the potential relationship between boron levels and periodontal inflammation and oxidative stress.

研究概览

详细说明

Periodontitis is a chronic inflammatory disease characterized by the destruction of the tooth-supporting tissues and is associated with an imbalance between oxidative stress and antioxidant defense mechanisms. Boron is a trace element that has been suggested to have potential roles in antioxidant and inflammatory processes; however, its relationship with periodontal disease remains unclear.

This cross-sectional observational study will include 60 systemically healthy, non-smoking participants: 30 periodontally healthy individuals and 30 patients diagnosed with Stage III-IV periodontitis. Periodontal clinical parameters will be recorded for all participants.

Unstimulated saliva samples will be collected before periodontal surgical procedures. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures, including crown-lengthening procedures in periodontally healthy participants and periodontal surgery in participants with periodontitis.

Boron levels will be determined in saliva and gingival tissue samples. Oxidative stress and antioxidant defense will be evaluated using selected biomarkers, including reactive oxygen species, total oxidant status, malondialdehyde, total antioxidant status, glutathione, superoxide dismutase, and catalase. Interleukin-1 beta will be evaluated as an inflammatory marker.

Boron levels and biochemical parameters will be compared between periodontally healthy individuals and participants with periodontitis, and their relationships with periodontal clinical parameters, oxidative stress, antioxidant defense, and inflammation will be investigated.

研究类型

观察性的

注册 (估计的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Maltepe
      • Istanbul、Maltepe、土耳其(türkiye)、34854
        • 招聘中
        • : Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul,
        • 接触:

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

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

The study population will consist of 60 systemically healthy individuals aged 18-65 years attending the Department of Periodontology, Faculty of Dentistry, Marmara University. Participants will be divided into two groups: 30 individuals with Stage III-IV periodontitis with an indication for periodontal flap surgery and 30 periodontally healthy individuals with an indication for crown-lengthening surgery.

描述

Inclusion Criteria:

  • Volunteering to participate in the study and signing the informed consent form
  • Being between 18 and 65 years of age
  • Being systemically healthy
  • No antibiotic use within the last 3 months
  • No periodontal treatment within the last 6 months
  • Being a non-smoker or having quit smoking at least 5 years ago
  • Not being pregnant or breastfeeding
  • No current use of steroids, immunosuppressive drugs, or non-steroidal anti-inflammatory drugs
  • No current use of medications associated with gingival enlargement, such as calcium channel blockers, phenytoin, or cyclosporine
  • No regular use of boron-containing supplements or multivitamin complexes
  • For the periodontally healthy group: no clinical attachment loss, bleeding on probing <10%, probing depth ≤3 mm, no radiographic bone loss, and an indication for crown-lengthening surgery
  • For the periodontitis group: diagnosis of Stage III or IV periodontitis according to the 2017 World Workshop classification and an indication for periodontal flap surgery

Exclusion Criteria:

  • Incomplete or unreliable clinical measurements
  • Insufficient saliva or gingival tissue sample for biochemical analyses
  • Regular use of boron-containing oral care products within the last 3 months
  • Regular consumption of boron-rich supplements or mineral waters
  • Failure to comply with the study protocol

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

队列和干预

团体/队列
干预/治疗
Periodontitis Group
Systemically healthy, non-smoking individuals diagnosed with Stage III-IV periodontitis who are scheduled for clinically indicated periodontal surgical treatment.
Unstimulated saliva and gingival tissue samples will be collected from participants. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures. The samples will be biochemically analyzed to determine boron levels and markers of oxidative stress, antioxidant defense, and inflammation. No experimental treatment or therapeutic intervention will be administered as part of the study.
Periodontally Healthy Group
Systemically healthy, non-smoking individuals with periodontal health who are scheduled for clinically indicated crown-lengthening surgery.
Unstimulated saliva and gingival tissue samples will be collected from participants. Gingival tissue samples will be obtained during clinically indicated periodontal surgical procedures. The samples will be biochemically analyzed to determine boron levels and markers of oxidative stress, antioxidant defense, and inflammation. No experimental treatment or therapeutic intervention will be administered as part of the study.

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
Boron Levels in Saliva and Gingival Tissue
大体时间:At the time of the clinically indicated periodontal surgical procedure
Boron levels will be measured in unstimulated saliva and gingival tissue samples obtained from participants in the periodontitis and periodontally healthy groups. Salivary boron levels will be expressed as µg/mL and gingival tissue boron levels as µg/g.
At the time of the clinically indicated periodontal surgical procedure

次要结果测量

结果测量
措施说明
大体时间
Oxidative Stress Markers
大体时间:At the time of the clinically indicated periodontal surgical procedure
Oxidative stress will be assessed by measuring reactive oxygen species (ROS), total oxidant status (TOS), and malondialdehyde (MDA) levels in samples obtained from the periodontitis and periodontally healthy groups.
At the time of the clinically indicated periodontal surgical procedure
Antioxidant Defense Markers
大体时间:At the time of the clinically indicated periodontal surgical procedure
Antioxidant defense will be assessed by measuring total antioxidant status (TAS), glutathione (GSH), superoxide dismutase (SOD), and catalase (CAT) levels in samples obtained from the periodontitis and periodontally healthy groups.
At the time of the clinically indicated periodontal surgical procedure
Inflammatory Marker
大体时间:At the time of the clinically indicated periodontal surgical procedure
Inflammation will be assessed by measuring interleukin-1 beta (IL-1β) levels in samples obtained from the periodontitis and periodontally healthy groups.
At the time of the clinically indicated periodontal surgical procedure

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。

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 (实际的)

2026年2月26日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年8月16日

首先提交符合 QC 标准的

2026年8月16日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月16日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared, as data sharing beyond the scope of the present study was not included in the approved study protocol and informed consent process.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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