Influence of the Regular Consumption of a Nitrate Containing Juice Beverage on Gingival Inflammation and the Salivary Nitrate/Nitrite Relationship in Periodontitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Gingival Index
研究概览
简要总结
The aim of this investigation is to evaluate the impact of the 14- day consumption of a nitrate-rich diet on the the extent of gingival inflammation in a cohort of periodontal aftercare patients. Recorded parameters were gingival index, plaque control record, salivary nitrate/nitrite level and vascular parameters
详细描述
This investigation evaluated the impact of a nitrate-rich diet on the extent of gingival inflammation in a cohort of periodontal aftercare patients. Forty-four (23 test/21 placebo) periodontal aftercare patients with chronic gingivitis were enrolled. At baseline, gingival index (GI), plaque con- trol record (PCR) and salivary nitrate level (SNL) were recorded, followed by sub- and supragingival debridement. Subsequently, participants were randomly provided with 100 ml bottles of a lettuce juice beverage to be consumed 39 daily over 14 days, containing either a standardized amount of nitrate resulting in an intake of approximately 200 mg nitrate per day (test) or being devoid of nitrate (placebo).
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
Patients were allocated using a computer-generated randomization list in blocks of six either to the test or the placebo group. Assignment to a participant number was done according to the chronological order of enrolment in the study. All therapeutic and diagnostic interventions were performed at the Department of Periodontology of the University Hospital of Wuerzburg. All examinations were performed by two experienced, inter- and intra-calibrated periodontists not being involved in patient assignment and hand out of the experimental juices respectively.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •number of teeth ≥ 10
- •body mass index (BMI) ≥ 24 ≤ 30
- •presence of mild to moderate gingivitis (Gingiva Index > category GI 0 ≤ category GI 2) at a minimum of 3 teeth
- •history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)
排除标准
- •manifestation of severe gingivitis (Gingiva Index = 3) at any tooth
- •manifestation of inflammatory oral mucosal diseases other than gingivitis
- •xerostomia (salivary flow ≤ 0.1 ml/minute)
- •inability for regular oral home care
- •known allergies and intolerances to any of the ingredients of the experimental juice beverages
- •inability to follow the study protocol due to intellectual or physical handicaps
研究组 & 干预措施
Nitrate-rich Diet
Daily consumption of 200 mg nitrate via the consumption of 300 mL of a nitrate-rich lettuce juice beverage.
干预措施: nitrate-rich lettuce juice (Dietary Supplement)
Nitrate-depleted Diet
Daily consumption of 300 mL of a nitrate-depleted lettuce juice beverage.
干预措施: nitrate-depleted lettuce juice (Dietary Supplement)
结局指标
主要结局
Gingival Index
时间窗: Day 14
Gingival Index will be recorded visually according to the modification of the original
Gingival Index
时间窗: Baseline
Gingival Index will be recorded visually according to the modification of the original GI by Lobene et al.
次要结局
- Peripheral blood pressure (systolic pressure, diastolic pressure)(Day 14)
- Salivary nitrite level(Day 14)
- Salivary nitrate level(Day 14)
- Central blood pressure (systolic pressure, diastolic pressure)(Day 14)
- Composition the oral microbiota(Day 14)
- Composition the oral microbiota(Baseline)
- Salivary nitrite level(Baseline)
- Salivary nitrate level(Baseline)
- Central blood pressure (systolic pressure, diastolic pressure)(Baseline)
- Peripheral blood pressure (systolic pressure, diastolic pressure)(Baseline)
研究者
Dr. Yvonne Jockel-Schneider
Prof. Dr. med. dent.
Wuerzburg University Hospital