FAVOURITE: Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

Sponsor

University of Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT01145820

Collaborator

NSA, Inc (Other)

246

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Morbidity Trauma Wound Healing	Dietary Supplement: Juice plus	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Juice Plus	Dietary Supplement: Juice plus Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Placebo Comparator: Placebo	Dietary Supplement: Juice plus Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)

Arm

Intervention/Treatment

Experimental: Juice Plus

Dietary Supplement: Juice plus

Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)

Placebo Comparator: Placebo

Dietary Supplement: Juice plus

Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)

Outcome Measures

Primary Outcome Measures

Quality of Life [first postoperative week]
QOL as assessed by PoSSe scale (Ruta et al., 2000)

Secondary Outcome Measures

trismus [postoperative week]
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
postoperative pain [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
analgesic use [first postoperative week]
plasma total antioxidant capacity (TAOC) [baseline (preop) and 1 week postop]
group differences between plasma TAOC changes between baseline and 1 week postop
serum biomarkers of oxidative stress [first postoperative week (baseline and 1 week)]
differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG
serum concentration of acute phase reactants [first postoperative week]
change between baseline and 1 week of: CRP, fibrinogen, WBC
adverse events [first postoperative week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.