Impact of a Dietary Supplementation With Maritime Pine Bark Extract (Pycnogenol®) on Gingival Inflammation - a Randomized Clinical Trial (PINEGIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Bleeding on Probing (BoP)
研究概览
简要总结
This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing Maritime Pine (Pinus pinaster) bark extract (Pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients
详细描述
Polyphenols are natural compounds produced by plants that have various functions, such as defence against microbial pathogens or protection against UV light. Based on their antioxidant activity, a soothing or preventive effect of polyphenols on various inflammatory diseases has been suspected. There is evidence of an anti-inflammatory effect of polyphenols in manifest periodontitis as well as antibacterial properties of these compounds. In addition, it is discussed that dietary polyphenols intervene in mechanisms involved in the pathophysiology of arteriosclerotic changes and their progression.
This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing Maritime Pine (Pinus pinaster) bark extract (Pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The experimental pine bark dietary supplement is packaged in neutral capsules, which are dispensed to the study patients in bottles with code labels.
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •number of teeth ≥ 10
- •age ≥ 35 ≤ 90 years
- •body mass index (BMI) ≥ 20 ≤ 30
- •history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)
- •minimum of 10% probing sites displaying bleeding on probing
排除标准
- •manifestation of inflammatory oral mucosal diseases other than gingivitis
- •xerostomia (stimulated salivary flow ≤ 0.1 ml/minute)
- •inability to perform regular oral home care
- •inability to follow the study protocol due to intellectual or physical handicaps
- •history of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years
- •current pregnancy
- •acute infections such as HIV
- •manifestation of metabolic bone disease
- •use of antibiotics and/or anti-inflammatory medications within 4 weeks prior to screening.
- •current orthodontic therapy
结局指标
主要结局
Bleeding on Probing (BoP)
时间窗: 6 months
Bleeding on Probing (BoP) is defined as the appearance of a bleeding spot within 30 seconds after gently probing the evaluated periodontal pocket by inserting the periodontal probe up to the probable bottom of the pocket.
次要结局
- Change in central aortal pulse pressure(3 months)
- Change in polyphenol serum concentration(3 months)
- Change in salivary levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors(6 months)
- Change in peripheral systolic and diastolic blood pressure(3 months)
- Compositional changes within the intestinal microbiota(6 months)
- Compositional changes within the oral microbiota(6 months)
- Change in salivary polyphenol concentration(3 months)
- Change in pulse wave velocity(3 months)
- Gingival Index GI(6 months)
- Plaque Control Record (PlaCR)(6 months)
- Change in periodontally inflamed surface area (PISA)(6 months)
- Change in serum levels of cytokines, cytokine inhibitors, matrix metalloproteinases and MMP inhibitors(6 months)