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Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth (FAVOURITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01145820
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : October 9, 2013
Sponsor:
Collaborator:
NSA, Inc
Information provided by (Responsible Party):
Thomas Dietrich, Dr. med., Dr. med. dent., MPH, University of Birmingham

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date October 9, 2013
Study Start Date  ICMJE June 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
Quality of Life [ Time Frame: first postoperative week ]
QOL as assessed by PoSSe scale (Ruta et al., 2000)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
  • trismus [ Time Frame: postoperative week ]
    trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
  • postoperative pain [ Time Frame: 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 [ Time Frame: first postoperative week ]
  • plasma total antioxidant capacity (TAOC) [ Time Frame: baseline (preop) and 1 week postop ]
    group differences between plasma TAOC changes between baseline and 1 week postop
  • serum biomarkers of oxidative stress [ Time Frame: 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 [ Time Frame: first postoperative week ]
    change between baseline and 1 week of: CRP, fibrinogen, WBC
  • adverse events [ Time Frame: first postoperative week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Postoperative Morbidity
  • Trauma
  • Wound Healing
Intervention  ICMJE Dietary Supplement: Juice plus
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Study Arms  ICMJE
  • Experimental: Juice Plus
    Intervention: Dietary Supplement: Juice plus
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Juice plus
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2013)
246
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)
200
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01145820
Other Study ID Numbers  ICMJE RG_09-111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Dietrich, Dr. med., Dr. med. dent., MPH, University of Birmingham
Study Sponsor  ICMJE University of Birmingham
Collaborators  ICMJE NSA, Inc
Investigators  ICMJE
Principal Investigator: Thomas Dietrich, DMD, MD, MPH University of Birmingham
Principal Investigator: Iain Chapple, BDS, PhD Unversity of Birmingham
PRS Account University of Birmingham
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP