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

This study has been completed.
Sponsor:
Collaborator:
NSA, Inc
Information provided by (Responsible Party):
Thomas Dietrich, Dr. med., Dr. med. dent., MPH, University of Birmingham
ClinicalTrials.gov Identifier:
NCT01145820
First received: June 16, 2010
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention
Postoperative Morbidity
Trauma
Wound Healing
Dietary Supplement: Juice plus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: first postoperative week ] [ Designated as safety issue: No ]
    QOL as assessed by PoSSe scale (Ruta et al., 2000)


Secondary Outcome Measures:
  • trismus [ Time Frame: postoperative week ] [ Designated as safety issue: No ]
    trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient

  • postoperative pain [ Time Frame: postoperative week ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • plasma total antioxidant capacity (TAOC) [ Time Frame: baseline (preop) and 1 week postop ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    change between baseline and 1 week of: CRP, fibrinogen, WBC

  • adverse events [ Time Frame: first postoperative week ] [ Designated as safety issue: Yes ]

Enrollment: 246
Study Start Date: June 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145820

Locations
United Kingdom
University of Birmingham
Birmingham, West Midlands, United Kingdom, B18 4DA
Sponsors and Collaborators
University of Birmingham
NSA, Inc
Investigators
Principal Investigator: Thomas Dietrich, DMD, MD, MPH University of Birmingham
Principal Investigator: Iain Chapple, BDS, PhD Unversity of Birmingham
  More Information

No publications provided

Responsible Party: Thomas Dietrich, Dr. med., Dr. med. dent., MPH, Principle Investigator, University of Birmingham
ClinicalTrials.gov Identifier: NCT01145820     History of Changes
Other Study ID Numbers: RG_09-111
Study First Received: June 16, 2010
Last Updated: October 8, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Birmingham:
third molar
trauma
pain
wound healing
post operative morbidity
acute trauma
short-term wound healing

ClinicalTrials.gov processed this record on November 25, 2014