Clinical trial NCT01145820: Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Morbidity
Trauma
Wound Healing
Keywords: third molar
trauma
pain
wound healing
post operative morbidity
acute trauma
short-term wound healing
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: NSA, Inc
First posted: 2010-06-17
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patient requiring surgical removal of a single (unilateral) mandibular wisdom tooth
2. Tooth requiring full mucoperiosteal flap to be raised for removal
3. Bone removal necessary during procedure.

Exclusion Criteria:

1. Patients refusing to give written informed consent
2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator
3. Pregnant or breast-feeding women
4. Patients taking long term anti-microbial or anti-inflammatory drugs
5. Patients unable to swallow Juice Plus capsules
6. Patients taking regular vitamin or mineral supplementation
7. Patients requiring pre-operative antibiotics for surgery
8. Patients requiring concomitant extractions or contralateral lower 3rd molar removal
9. Allergic to any of the ingredients contained in supplements or placebo medication.

Primary outcomes:
measure: Quality of Life
timeFrame: first postoperative week
Secondary outcomes:
measure: trismus
timeFrame: postoperative week
measure: postoperative pain
timeFrame: postoperative week
measure: analgesic use
timeFrame: first postoperative week
measure: plasma total antioxidant capacity (TAOC)
timeFrame: baseline (preop) and 1 week postop
measure: serum biomarkers of oxidative stress
timeFrame: first postoperative week (baseline and 1 week)
measure: serum concentration of acute phase reactants
timeFrame: first postoperative week
measure: adverse events
timeFrame: first postoperative week
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Thomas Dietrich, DMD, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Unversity of Birmingham
name: Iain Chapple, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorecki P, Burke DL, Chapple ILC, Hemming K, Saund D, Pearson D, Stahl W, Lello R, Dietrich T. Perioperative supplementation with a fruit and vegetable juice powder concentrate and postsurgical morbidity: A double-blind, randomised, placebo-controlled clinical trial. Clin Nutr. 2018 Oct;37(5):1448-1455. doi: 10.1016/j.clnu.2017.08.004. Epub 2017 Aug 10.