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Completed

NCT Number: NCT01145820

Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth

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.

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Key information

Conditions

Postoperative Morbidity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma Wound Healing Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Birmingham

Birmingham, West Midlands, B18 4DA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Juice Plus

Dietary Supplement

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

Primary outcomes

  1. Quality of Life

    Time frame: first postoperative week

    QOL as assessed by PoSSe scale (Ruta et al., 2000)

Secondary outcomes

  1. trismus

    Time frame: postoperative week

    trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient

  2. 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

  3. analgesic use

    Time frame: first postoperative week

  4. 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

  5. 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

  6. serum concentration of acute phase reactants

    Time frame: first postoperative week

    change between baseline and 1 week of: CRP, fibrinogen, WBC

  7. adverse events

    Time frame: first postoperative week

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • NSA, Inc

Registry information

Official study 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

Acronym: FAVOURITE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2010
Registry last updated
Oct 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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