Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth (FAVOURITE)
Efficacy of Adjunctive Juice Plus in Reducing Post-operative Morbidity and Improving Quality of Life After Lower Third Molar Surgery: a Randomized Controlled Clinical Trial
The proposed study will test the following hypotheses:
- Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11 weeks will result in reduced post-operative morbidity in terms of quality of life, pain and trismus after 1 week following surgical removal of lower third molars, when compared to placebo.
- Pre-operative daily dual supplementation with Juice Plus+ (fruit & vegetable) for 11 weeks will reduce serum markers of oxidative stress, following surgical removal of lower third molars, when compared with placebo.
研究概览
详细说明
In general antioxidant status appears to influence wound healing in humans and in animal models of acute trauma, with low antioxidant concentrations and excessive oxidative stress being associated with impaired healing. Whilst antioxidant supplementation has been reported to improve plasma antioxidant status and wound healing in animal models of acute trauma, there is remarkably little data from human studies.
The use of Juice Plus+ has been reported to increase serum concentrations of important antioxidants and reduce serum markers of oxidative stress. However, to date there are no reported studies concerning the potential for Juice Plus+ to improve patient-based outcome measures following the surgical removal of lower third molars. This study therefore proposes to investigate the impact of daily supplementation with Juice Plus+, in improving outcomes following surgical trauma. While the rationale for the proposed study is primarily predicated on the established role of oxidative stress and antioxidant micronutrients in chronic inflammatory diseases, the proposed randomized controlled clinical study represents an efficient way of evaluating the potential for adjunctive Juice Plus+ use in improving wound healing and reducing post-operative morbidity following surgical procedures on humans.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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West Midlands
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Birmingham、West Midlands、英国、B18 4DA
- University of Birmingham
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient requiring surgical removal of a single (unilateral) mandibular wisdom tooth
- Tooth requiring full mucoperiosteal flap to be raised for removal
- Bone removal necessary during procedure.
Exclusion Criteria:
- Patients refusing to give written informed consent
- Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
- Pregnant or breast-feeding women
- Patients taking long term anti-microbial or anti-inflammatory drugs
- Patients unable to swallow Juice Plus capsules
- Patients taking regular vitamin or mineral supplementation
- Patients requiring pre-operative antibiotics for surgery
- Patients requiring concomitant extractions or contralateral lower 3rd molar removal
- Allergic to any of the ingredients contained in supplements or placebo medication.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
|
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
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实验性的:果汁加
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Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quality of Life
大体时间:first postoperative week
|
QOL as assessed by PoSSe scale (Ruta et al., 2000)
|
first postoperative week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
trismus
大体时间:postoperative week
|
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
|
postoperative week
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postoperative pain
大体时间:postoperative week
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pain will be assessed by patient on VAS on each postop day. groups will be compared for the following:
|
postoperative week
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analgesic use
大体时间:first postoperative week
|
first postoperative week
|
|
plasma total antioxidant capacity (TAOC)
大体时间:baseline (preop) and 1 week postop
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group differences between plasma TAOC changes between baseline and 1 week postop
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baseline (preop) and 1 week postop
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serum biomarkers of oxidative stress
大体时间:first postoperative week (baseline and 1 week)
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differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG
|
first postoperative week (baseline and 1 week)
|
serum concentration of acute phase reactants
大体时间:first postoperative week
|
change between baseline and 1 week of: CRP, fibrinogen, WBC
|
first postoperative week
|
adverse events
大体时间:first postoperative week
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first postoperative week
|
合作者和调查者
合作者
调查人员
- 首席研究员:Thomas Dietrich, DMD, MD, MPH、University of Birmingham
- 首席研究员:Iain Chapple, BDS, PhD、Unversity of Birmingham
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RG_09-111
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
创伤的临床试验
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Riverside University Health System Medical Center未知
Juice plus的临床试验
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Birmingham Community Healthcare NHSNSA, LLC完全的
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University of ReadingJuice PLUS完全的
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InBios International, Inc.Biomedical Advanced Research and Development Authority; Fast-Track Drugs & Biologics, LLC完全的
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Azienda Sanitaria Locale Napoli 2 Nord招聘中
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Zona Health, IncResearch & Development Concierge Company终止