- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
West Midlands
-
Birmingham, West Midlands, Verenigd Koninkrijk, B18 4DA
- University of Birmingham
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Placebo
|
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
|
Experimenteel: Sap plus
|
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Quality of Life
Tijdsspanne: first postoperative week
|
QOL as assessed by PoSSe scale (Ruta et al., 2000)
|
first postoperative week
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
trismus
Tijdsspanne: postoperative week
|
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
|
postoperative week
|
postoperative pain
Tijdsspanne: 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
Tijdsspanne: first postoperative week
|
first postoperative week
|
|
plasma total antioxidant capacity (TAOC)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: first postoperative week
|
change between baseline and 1 week of: CRP, fibrinogen, WBC
|
first postoperative week
|
adverse events
Tijdsspanne: first postoperative week
|
first postoperative week
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Thomas Dietrich, DMD, MD, MPH, University of Birmingham
- Hoofdonderzoeker: Iain Chapple, BDS, PhD, Unversity of Birmingham
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RG_09-111
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Trauma
-
University Hospital, AngersWerving
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.VoltooidHoofdletsel Trauma BluntVerenigde Staten
-
Humacyte, Inc.Actief, niet wervendTrauma | Trauma letsel | Trauma, meerdere | Trauma botOekraïne
-
Assistance Publique - Hôpitaux de ParisFrancophone Pediatric Resuscitation and Emergency Group (GFRUP)Voltooid
-
University Hospital, ToulouseNog niet aan het werven
-
Marmara UniversityVoltooid
-
Centre Hospitalier Annecy GenevoisBeëindigd
-
Rabin Medical CenterIsraeli Ministry of SecurityOnbekend
-
Phoenix Children's HospitalOnbekendVerwaarlozing, kind | Hoofd trauma | Niet-toevallig trauma | Niet-accidenteel letsel aan kind
Klinische onderzoeken op Juice plus
-
The University of Tennessee, KnoxvilleNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Cherokee...VoltooidObesitas | Obesitas bij kinderenVerenigde Staten
-
ResMedVoltooidSlaapapneu, obstructief | Slaapapneu, CentraalDuitsland
-
Alma Lasers Inc.OnbekendAcne littekens | Rimpels | PigmentatieVerenigde Staten
-
University of TrierGerman Research FoundationVoltooidFeedback, psychologischDuitsland
-
Ethicon, Inc.Voltooid
-
National Institute of Diabetes and Digestive and...Voltooid
-
Farmaceutici Damor SpaWervingWonden en verwondingen | Wond infectie | Wond geneestItalië
-
Zhejiang Cancer HospitalWervingGalweg AdenocarcinoomChina
-
National Taiwan University HospitalWerving
-
University of PittsburghVoltooidKwaliteit van het leven | Obesitas | Fysieke activiteit | Dieet Wijziging | Cardiovasculaire risicofactor | Mobiliteitsbeperking | Eetgedrag