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Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth (FAVOURITE)

2013年10月8日 更新者:Thomas Dietrich, Dr. med., Dr. med. dent., MPH、University of Birmingham

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:

  1. 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.
  2. 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

介入性

注册 (实际的)

246

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • West Midlands
      • Birmingham、West Midlands、英国、B18 4DA
        • University of Birmingham

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patient requiring surgical removal of a single (unilateral) mandibular wisdom tooth
  2. Tooth requiring full mucoperiosteal flap to be raised for removal
  3. Bone removal necessary during procedure.

Exclusion Criteria:

  1. Patients refusing to give written informed consent
  2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
  3. Pregnant or breast-feeding women
  4. Patients taking long term anti-microbial or anti-inflammatory drugs
  5. Patients unable to swallow Juice Plus capsules
  6. Patients taking regular vitamin or mineral supplementation
  7. Patients requiring pre-operative antibiotics for surgery
  8. Patients requiring concomitant extractions or contralateral lower 3rd molar removal
  9. Allergic to any of the ingredients contained in supplements or placebo medication.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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)
实验性的:果汁加
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
postoperative pain
大体时间:postoperative week

pain will be assessed by patient on VAS on each postop day. groups will be compared for the following:

  • total (sum) of pain scores over 1 week
  • proportion of patients reporting >50% pain on day 2 and day 7
  • time until pain consistently <50%
  • proportion of patients reporting 20mm increase in pain after postoperative day 3
postoperative week
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
group differences between plasma TAOC changes between baseline and 1 week postop
baseline (preop) and 1 week postop
serum biomarkers of oxidative stress
大体时间:first postoperative week (baseline and 1 week)
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
first postoperative week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年6月1日

初级完成 (实际的)

2013年4月1日

研究完成 (实际的)

2013年4月1日

研究注册日期

首次提交

2010年6月16日

首先提交符合 QC 标准的

2010年6月16日

首次发布 (估计)

2010年6月17日

研究记录更新

最后更新发布 (估计)

2013年10月9日

上次提交的符合 QC 标准的更新

2013年10月8日

最后验证

2013年10月1日

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.

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