NCT01145820

Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Morbidity
• Trauma
• Wound Healing

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Juice plus	Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-06-17
• Last updated: 2013-10-09

Locations

1 site across 1 country: United Kingdom