Postoperative MorbidityFAVOURITENCT01145820
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
A study testing Juice plus in people with Postoperative Morbidity and Trauma, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Morbidity, Trauma, Wound Healing
- What is being tested?
- Juice plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Birmingham, West Midlands, B18 4DA
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Morbidity, Trauma, Wound Healing
- Being tested
- Juice plus
- Keywords
- third molar, trauma, pain, wound healing, post operative morbidity, acute trauma, short-term wound healing
- Medical subject headings
- Wounds and Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juice plusDietary supplement
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
| Study group | Role | What they receive |
|---|---|---|
| Juice Plus | Experimental | Not described Receives: Dietary Supplement: Juice plus |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Juice plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
QOL as assessed by PoSSe scale (Ruta et al., 2000)
Measured: first postoperative week
Secondary outcomes (7)
trismus
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
Measured: postoperative week
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
Measured: postoperative week
analgesic use
Measured: first postoperative week
plasma total antioxidant capacity (TAOC)
group differences between plasma TAOC changes between baseline and 1 week postop
Measured: baseline (preop) and 1 week postop
serum biomarkers of oxidative stress
differences in change from baseline to 1 week of mean protein carbonyls, isoprostanes and 8OHdG
Measured: first postoperative week (baseline and 1 week)
serum concentration of acute phase reactants
change between baseline and 1 week of: CRP, fibrinogen, WBC
Measured: first postoperative week
adverse events
Measured: first postoperative week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- NSA, Inc
- Responsible party
- Principal investigator, Thomas Dietrich, Dr. med., Dr. med. dent., MPH, University of Birmingham
- Investigators
- Thomas Dietrich, DMD, MD, MPH, Principal investigator, University of BirminghamIain Chapple, BDS, PhD, Principal investigator, Unversity of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145820
- Sponsor's protocol ID
- RG_09-111
- Acronym
- FAVOURITE
- Status last verified
- Oct 2013
- First submitted
- 16 Jun 2010
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28866140
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01145820
- Acronym / sponsor ID
- FAVOURITE / RG_09-111
- Conditions
- Postoperative Morbidity, Trauma, Wound Healing
- Keywords
- third molar, trauma, pain, wound healing, post operative morbidity, acute trauma, short-term wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- NSA, Inc
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juice Plus | Experimental | Dietary Supplement: Juice plus |
| Placebo | Placebo comparator | Dietary Supplement: Juice plus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juice plusJuice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop) | Dietary supplement | Juice Plus, Placebo |
Primary outcome
Quality of Life
Time frame: first postoperative week
QOL as assessed by PoSSe scale (Ruta et al., 2000)
7 secondary outcomes
trismus
Time frame: postoperative week
postoperative pain
Time frame: postoperative week
analgesic use
Time frame: first postoperative week
plasma total antioxidant capacity (TAOC)
Time frame: baseline (preop) and 1 week postop
serum biomarkers of oxidative stress
Time frame: first postoperative week (baseline and 1 week)
serum concentration of acute phase reactants
Time frame: first postoperative week
adverse events
Time frame: first postoperative week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
- Derived from this study: PubMed 28866140Gorecki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Dietrich, DMD, MD, MPH principal investigator
University of Birmingham
Iain Chapple, BDS, PhD principal investigator
Unversity of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juice plus in people with Postoperative Morbidity and Trauma, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: first postoperative week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2013.