Dietary Intake of Collagen Peptides and Its Effects on Periodontal Inflammation - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Percentage of periodontal sites being positive for 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 collagen peptides on the clinical signs of gingival and periodontal inflammation in a cohort of patients suffering from periodontal disease.
详细描述
The positive influence of the regular consumption of bioactive collagen peptides on connective tissue and skin physiology has already been documented by several clinical trials. Preliminary data of an observational clinical trial involving periodontitis patients suggest that the adjunctive consumption of bio-active collagen peptides may also improve the outcome of established periodontitis therapy comprising the professional mechanical removal of disease-associated bacterial biofilms from exposed root surfaces.
This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular, 3-month consumption of collagen peptides on clinical and microbiological parameter of periodontal health in a cohort of periodontal recall patients with the following endpoints:
Primary Endpoint:
Change in the percentage of periodontal pockets being positive for bleeding on probing (BoP) after the consumption of the collagen peptides in comparison to the consumption of a placebo product
Secondary Endpoints:
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
- Double (Participant, Investigator)
盲法说明
test and placebo powder contained in coded blister packages of identical shape and colour Handing out of the assigned powder by a study nurse not involved in the clinical examination and data collection
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
- 否
入选标准
- •number of teeth ≥ 10
- •age ≥ 35 ≤ 70 years
- •body mass index (BMI) ≥ 24 ≤ 30
- •history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)
- •presence of mild to moderate gingivitis (Gingiva Index > category GI 0 ≤ category GI 2) at a minimum of 3 teeth
排除标准
- •manifestation of inflammatory oral mucosal diseases other than gingivitis
- •xerostomia (salivary flow ≤ 0.1 ml/minute)
- •inability for 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 as HIV
- •existence of metabolic bone disease
- •smoking status of more than 10 cigarettes/day
- •use of antibiotics and/or anti-inflammatory medication within 4 weeks prior to screening.
- •active orthodontic therapy
- •diabetes mellitus type I and II
- •regular consumption of medications interfering with gingival inflammation (e.g. cortisol)
结局指标
主要结局
Percentage of periodontal sites being positive for bleeding on probing (BoP)
时间窗: 90 days
Bleeding on probing will be recorded at 6 sites per tooth after gentle probing of the periodontal sulcus/pocket.
次要结局
- clinical attachment level (CAL)(90 days)
- pocket probing depth (PPD)(90 days)
- periodontal inflamed surface area (PISA)(90 days)
- modified Gingival Index(90 days)
- Plaque Control Record(90 days)
- Plaque Index(90 days)
- Composition of the oral microbiota(90 days)
- Composition of the intestinal microbiota(90 days)