- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01145820
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth (FAVOURITE)
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:
- 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.
- 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
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom, B18 4DA
- University of Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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:
|
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
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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.
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