The Effect of Daily Dietary Intake of Dried Whole Food Concentrates of Fruit, Vegetables and Berries (Juice Plus+) in Improving Clinical Outcomes Following Non-surgical Periodontal Therapy: a Pilot Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Primary outcome measure of healing will be increases in attachment level and reduction in probing pocket depths at 3-months.
研究概览
简要总结
There are 3 hypotheses to be tested:
- That daily supplementation with Juice Plus+ will significantly improve treatment outcomes over placebo supplementation, at 3-months post-therapy, when used as an adjunct to conventional non-surgical periodontal therapy.
- Triple therapy with Juice Plus+ (fruit, vegetable & berry) will produce additional treatment benefit over dual therapy (fruit & vegetable) and over placebo.
- Improved treatment outcomes with Juice Plus+ will be maintained at 9-months post-therapy.
Brief Summary:
Periodontal diseases are highly prevalent chronic inflammatory diseases and a major cause of tooth loss. Data supports an association between periodontitis prevalence and reduced serum levels of antioxidants. Anecdotal reports from periodontal specialists indicate significant improvements in clinical outcomes from periodontal therapy where adjunctive Juice Plus+ is used, in agreement with research data from other systemic diseases where hyper-inflammation is implicated in disease pathogenesis. There is however, a lack of scientific evidence from clinical trials of periodontitis. Given the demonstrable antioxidant deficiency in periodontitis patients (both locally and peripherally), the excess oxidative stress in periodontitis patients, and the anecdotal evidence of clinical benefit from the adjunctive use of Juice Plus+, this study proposes to investigate the impact of daily supplementation with Juice Plus+ as an adjunct to traditional non-surgical periodontal therapy, in improving therapeutic outcomes.
详细描述
This will be a longitudinal, randomised, stratified (for age), double-blind, 3-arm study of non-surgical periodontal therapy. The 3 arms will be:
- Daily Juice Plus+ with 2 vegetable & 2 fruit & 2 berry capsule (test group 1)
- Daily Juice Plus+ with 2 vegetable & 2 fruit & 2 placebo capsule (test group 2)
- Daily Placebo in the form of 6 capsules (control group)
Volunteers will receive standard non-surgical periodontal therapy by a single operator (study hygienist) and outcome measures will be assessed at baseline, 3, 6 and 9-months post-therapy. Capsules will be taken with food twice daily (3 capsules am & 3 capsules pm).
60 non-smoking patients with chronic moderate/severe periodontitis will be recruited from outpatient periodontal clinics at Birmingham's Dental Hospital. Subjects will be 30-60 years of age, male or female. Chronic periodontitis (CP) will be defined as the presence of 2 or more sites per quadrant with pocketing or interproximal attachment loss of > 6mm and 1/3rd radiographic bone loss.
The following exclusion criteria will apply:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic periodontitis
- •Presence of 2 or more sites per quadrant with pocketing or interproximal attachment loss of greater than 6mm and 1/3rd radiographic bone loss
排除标准
- •Subjects with aggressive disease
- •Subjects with physical or mental disability
- •Pregnant women
- •Subjects whose medical history may place them at risk of complications from periodontal therapy (e.g. need for antibiotic cover, warfarinised subjects)
- •Subjects taking long term anti-microbial or anti-inflammatory drugs
- •Subjects unable to swallow Juice Plus+ capsules
- •Subjects unable to provide informed consent
- •Current smokers
- •Subjects taking regular vitamin supplementation
结局指标
主要结局
Primary outcome measure of healing will be increases in attachment level and reduction in probing pocket depths at 3-months.
时间窗: 3, 6 and 9-months
次要结局
- Secondary outcome measures will be reduction in % sites with disclosed plaque (PS - measured dichotomously at 4 sites per tooth), reductions in gingival crevicular fluid (GCF) volume, increases in GCF and plasma TAOC.(3, 6 and 9-months)
研究者
Professor I Chapple
Professor (PI for study)
Birmingham Community Healthcare NHS
