Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
NCT ID: NCT01145820
Last Updated: 2013-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2010-06-30
2013-04-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Juice Plus
Juice plus
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Placebo
Juice plus
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Interventions
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Juice plus
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Eligibility Criteria
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Inclusion Criteria
2. Tooth requiring full mucoperiosteal flap to be raised for removal
3. Bone removal necessary during procedure.
Exclusion Criteria
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.
18 Years
60 Years
ALL
No
Sponsors
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NSA, Inc
UNKNOWN
University of Birmingham
OTHER
Responsible Party
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Thomas Dietrich, Dr. med., Dr. med. dent., MPH
Principle Investigator
Principal Investigators
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Thomas Dietrich, DMD, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Iain Chapple, BDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Unversity of Birmingham
Locations
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University of Birmingham
Birmingham, West Midlands, United Kingdom
Countries
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References
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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.
Other Identifiers
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RG_09-111
Identifier Type: -
Identifier Source: org_study_id