Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth (FAVOURITE)
Primary Purpose
Postoperative Morbidity, Trauma, Wound Healing
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Juice plus
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Morbidity focused on measuring third molar, trauma, pain, wound healing, post operative morbidity, acute trauma, short-term wound healing
Eligibility Criteria
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.
Sites / Locations
- University of Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Juice Plus
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Quality of Life
QOL as assessed by PoSSe scale (Ruta et al., 2000)
Secondary Outcome Measures
trismus
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
postoperative pain
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
plasma total antioxidant capacity (TAOC)
group differences between plasma TAOC changes between baseline and 1 week postop
serum biomarkers of oxidative stress
differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG
serum concentration of acute phase reactants
change between baseline and 1 week of: CRP, fibrinogen, WBC
adverse events
Full Information
NCT ID
NCT01145820
First Posted
June 16, 2010
Last Updated
October 8, 2013
Sponsor
University of Birmingham
Collaborators
NSA, Inc
1. Study Identification
Unique Protocol Identification Number
NCT01145820
Brief Title
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
Acronym
FAVOURITE
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Birmingham
Collaborators
NSA, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Morbidity, Trauma, Wound Healing
Keywords
third molar, trauma, pain, wound healing, post operative morbidity, acute trauma, short-term wound healing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Juice Plus
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice plus
Intervention Description
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
Primary Outcome Measure Information:
Title
Quality of Life
Description
QOL as assessed by PoSSe scale (Ruta et al., 2000)
Time Frame
first postoperative week
Secondary Outcome Measure Information:
Title
trismus
Description
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
Time Frame
postoperative week
Title
postoperative pain
Description
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
Time Frame
postoperative week
Title
analgesic use
Time Frame
first postoperative week
Title
plasma total antioxidant capacity (TAOC)
Description
group differences between plasma TAOC changes between baseline and 1 week postop
Time Frame
baseline (preop) and 1 week postop
Title
serum biomarkers of oxidative stress
Description
differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG
Time Frame
first postoperative week (baseline and 1 week)
Title
serum concentration of acute phase reactants
Description
change between baseline and 1 week of: CRP, fibrinogen, WBC
Time Frame
first postoperative week
Title
adverse events
Time Frame
first postoperative week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dietrich, DMD, MD, MPH
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iain Chapple, BDS, PhD
Organizational Affiliation
Unversity of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B18 4DA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28866140
Citation
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.
Results Reference
derived
Learn more about this trial
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
We'll reach out to this number within 24 hrs