Evaluation of the Relationship Between Boron Levels and Oxidative Stress, Antioxidant Defense, and Inflammatory Markers in Individuals With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Boron Levels in Saliva and Gingival Tissue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Periodontitis Group
Systemically healthy, non-smoking individuals diagnosed with Stage III-IV periodontitis who are scheduled for clinically indicated periodontal surgical treatment.
干预措施: Biochemical Assessment of Saliva and Gingival Tissue (Other)
Periodontally Healthy Group
Systemically healthy, non-smoking individuals with periodontal health who are scheduled for clinically indicated crown-lengthening surgery.
干预措施: Biochemical Assessment of Saliva and Gingival Tissue (Other)
结局指标
主要结局
Boron Levels in Saliva and Gingival Tissue
时间窗: 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.
次要结局
- Oxidative Stress Markers(At the time of the clinically indicated periodontal surgical procedure)
- Antioxidant Defense Markers(At the time of the clinically indicated periodontal surgical procedure)
- Inflammatory Marker(At the time of the clinically indicated periodontal surgical procedure)