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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Quality of Life
时间窗: first postoperative week
QOL as assessed by PoSSe scale (Ruta et al., 2000)
次要结局
- analgesic use(first postoperative week)
- plasma total antioxidant capacity (TAOC)(baseline (preop) and 1 week postop)
- adverse events(first postoperative week)
- trismus(postoperative week)
- postoperative pain(postoperative week)
- serum biomarkers of oxidative stress(first postoperative week (baseline and 1 week))
- serum concentration of acute phase reactants(first postoperative week)
研究者
Thomas Dietrich, Dr. med., Dr. med. dent., MPH
Principle Investigator
University of Birmingham