The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries (Juice Plus+) Upon Periodontal Outcomes in Chronic Periodontitis: A Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Changes in clinical parameters
研究概览
简要总结
The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to standard non-surgical treatment.
详细描述
The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to non-surgical treatment. In addition, the effects of supplementation prior to and following standard non-surgical management will be assessed, relative to a placebo supplemented group.
The investigators hypothesize that 3-months of nutritional support using this FVB will result in additional reductions in marginal gingival inflammation (bleeding) and additional reductions in probing pocket depth (mean & cumulative), over and above any placebo-related or behavioral effect. In addition, the investigators hypothesize that 3-months of nutritional support prior to a standard non-surgical therapy in conjunction with a continuation of the nutritional support for 3 months will result in further additional reductions in marginal gingival inflammation and probing pocket depth, over and above any placebo-related or behavioral effect following standard non-surgical therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be aged 18 years old and over
- •have a minimum of 20 teeth
- •have chronic periodontitis
- •be capable of giving informed consent themselves
排除标准
- •Patients with aggressive disease
- •Patients with physical or mental disability
- •Pregnant women or those breastfeeding
- •Patients whose medical history may place them at risk of complications from periodontal therapy (e.g. warfarinised Volunteers)
- •Patients taking long term anti-microbial or anti-inflammatory drugs
- •Patients unable to swallow the study capsules, or take 6 of these capsules a day
- •Patients unable to provide informed consent
- •Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils) or have taken them within 1-month of the study
- •Shows unwillingness, inability or lack of motivation to carry out the study procedures or is not prepared to give written consent or to refrain from using other oral hygiene products (mouthwashes, chewing gum, water piks etc.) or to undergo professional dental cleaning for the duration of the study (other than as part of this protocol)
- •Antibiotic or anti-inflammatory therapy currently or in previous two weeks
- •Current orthodontic treatment
- •Currently participating in another Dental Trial
- •Diabetics
结局指标
主要结局
Changes in clinical parameters
时间窗: 6 months
The primary outcomes will be differences in the changes in the parameters listed below at 6 months (3 months post supplementation + 3 months post treatment)in test and placebo groups % sites with marginal BOP from baseline. Probing pocket depth reductions (mm) from baseline (expressed as reductions in mean and also cumulative pocket depth).
次要结局
- Clinical and biochemical changes(6 months)
研究者
Professor I Chapple
Professor (PI to study)
Birmingham Community Healthcare NHS