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

October 8, 2013 updated by: Thomas Dietrich, Dr. med., Dr. med. dent., MPH, University of Birmingham

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 4DA
        • University of Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Experimental: Juice Plus
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: first postoperative week
QOL as assessed by PoSSe scale (Ruta et al., 2000)
first postoperative week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
trismus
Time Frame: postoperative week
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
postoperative week
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
postoperative week
analgesic use
Time Frame: first postoperative week
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
baseline (preop) 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
first postoperative week (baseline and 1 week)
serum concentration of acute phase reactants
Time Frame: first postoperative week
change between baseline and 1 week of: CRP, fibrinogen, WBC
first postoperative week
adverse events
Time Frame: first postoperative week
first postoperative week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Thomas Dietrich, DMD, MD, MPH, University of Birmingham
  • Principal Investigator: Iain Chapple, BDS, PhD, Unversity of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_09-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Clinical Trials on Juice plus

3
Subscribe