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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
246
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
University of Birmingham
Birmingham, West Midlands, United Kingdom
Quality of Life
QOL as assessed by PoSSe scale (Ruta et al., 2000)
Time frame: first postoperative week
trismus
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
Time frame: postoperative week
postoperative pain
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
Time frame: postoperative week
analgesic use
Time frame: first postoperative week
plasma total antioxidant capacity (TAOC)
group differences between plasma TAOC changes between baseline and 1 week postop
Time frame: baseline (preop) and 1 week postop
serum biomarkers of oxidative stress
differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG
Time frame: first postoperative week (baseline and 1 week)
serum concentration of acute phase reactants
change between baseline and 1 week of: CRP, fibrinogen, WBC
Time frame: first postoperative week
adverse events
Time frame: first postoperative week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.