The Effect of Non-Surgical Periodontal Treatment on Systemic Inflammatory Markers and Lipid Profile in Young Adults With Severe Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change in serum high-sensitivity C-reactive protein (hs-CRP) concentration after periodontal treatment
研究概览
简要总结
The goal of this clinical study was to evaluate whether non-surgical treatment for severe periodontitis (gum disease) could improve body-wide inflammation and blood fat levels in young adults with severe periodontitis. The main questions it aimed to answer were:
Did non-surgical periodontal treatment improve gum health in young adults with severe periodontitis?
Did non-surgical periodontal treatment change body-wide inflammation and blood fat levels after treatment?
Researchers compared participants with severe periodontitis to healthy participants without periodontitis.
Participants with severe periodontitis:
- Received oral hygiene instructions, deep cleaning below the gumline, root surface cleaning, and removal of teeth that could not be saved
- Had full-mouth gum examinations
- Provided blood samples at the start of the study and again at 2 and 6 months after treatment
Healthy participants:
- Had gum examinations
- Provided blood samples for comparison at the start of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 36 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults aged 19 to 36 years
- •At least 20 teeth present
- •Clinical attachment loss of at least 5 mm affecting at least 8 teeth
- •Bone loss around at least 3 teeth other than incisors and first molars
排除标准
- •Systemic disease
- •Pregnancy or lactation
- •Current or former smoking
- •Systemic conditions that could alter the host response
- •Medical conditions requiring antibiotic prophylaxis during routine dental procedures
- •Antibiotic therapy within the previous 6 months
- •Previous periodontal treatment
研究组 & 干预措施
Healthy Group
The healthy control arm included systemically and periodontally healthy young adults with no periodontal or systemic disease who met the same exclusion criteria as the periodontitis group. Participants did not receive periodontal treatment. They underwent baseline full-mouth periodontal examination and blood sampling to provide healthy reference values.
Periodontitis Group
The periodontitis arm included systemically healthy young adults with severe periodontitis. Participants underwent baseline full-mouth periodontal examination and blood sampling, received non-surgical periodontal treatment, and were re-evaluated at 2 and 6 months after treatment.
干预措施: Non-surgical periodontal treatment (Procedure)
结局指标
主要结局
The change in serum high-sensitivity C-reactive protein (hs-CRP) concentration after periodontal treatment
时间窗: 6 months
This change is measured in serum, as mg/dl, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. The study was powered on the change in this parameter from baseline to 6 months after treatment.
The change in HDL cholesterol concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in LDL cholesterol concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in total cholesterol concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in triglyceride concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in albumin concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in von Willebrand factor (vWf) level after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in creatinine concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in fibrinogen concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in Factor VII level after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in interleukin-1 receptor (IL-1ra) antagonist concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in interleukin-6 (IL-6) level after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in soluble tumor necrosis factor receptor I (sTNFRI) concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in soluble tumor necrosis factor receptor II concentration (sTNFRII) after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
The change in tissue plasminogen activator (tPA) concentration after periodontal treatment
时间窗: 6 months
This parameter is measured in blood samples, as ng/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment. It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
次要结局
- The change in sulcus bleeding index (SBI) after periodontal treatment(6 months)
- The change in plaque index (PI) after periodontal treatment(6 months)
- The change in clinical attachment level (CAL) after periodontal treatment(6 months)
- The change in probing pocket depth (PPD) after periodontal treatment(6 months)
- The change in level of gingival margin (LGM) after periodontal treatment(6 months)
研究者
Ülkü Başer
Prof. Dr.
Istanbul University