Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Postoperative Morbidity, Trauma, Wound Healing

Intervention / Treatment
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* Dietary Supplement: Juice plus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juice Plus<br> | Dietary Supplement: Juice plus<br>* Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Juice plus<br>* Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | QOL as assessed by PoSSe scale (Ruta et al., 2000) | first postoperative week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trismus | trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient | 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 | postoperative week | 
| analgesic use |  | first postoperative week | 
| plasma total antioxidant capacity (TAOC) | group differences between plasma TAOC changes between baseline and 1 week postop | 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 | first postoperative week (baseline and 1 week) | 
| serum concentration of acute phase reactants | change between baseline and 1 week of: CRP, fibrinogen, WBC | first postoperative week | 
| adverse events |  | first postoperative week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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third molar, trauma, pain, wound healing, post operative morbidity, acute trauma, short-term wound healing