Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth (FAVOURITE)
This study is currently recruiting participants.
Verified January 2012 by University of Birmingham
Sponsor:
University of Birmingham
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: January 24, 2012
Last verified: January 2012
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Purpose
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.
| 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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145820
Contacts
| Contact: Thomas Dietrich, DMD, MD, MPH | 0121 237 2825 | DietricT@adf.bham.ac.uk |
| Contact: Iain Chapple, BDS | 0121 237 2825 | chappilc@adf.bham.ac.uk |
Locations
| United Kingdom | |
| University of Birmingham | Recruiting |
| Birmingham, West Midlands, United Kingdom, B18 4DA | |
| Contact: Thomas Dietrich, DM 0121 237 2825 DietricT@adf.bham.ac.uk | |
| Contact: Daniel Saund, BDS 0121 237 2825 d.s.saund@bham.ac.uk | |
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: | January 24, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013