- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
West Midlands
-
Birmingham, West Midlands, Storbritannia, B18 4DA
- University of Birmingham
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
|
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
|
Eksperimentell: Juice Plus
|
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Quality of Life
Tidsramme: first postoperative week
|
QOL as assessed by PoSSe scale (Ruta et al., 2000)
|
first postoperative week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
trismus
Tidsramme: postoperative week
|
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
|
postoperative week
|
postoperative pain
Tidsramme: 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
Tidsramme: first postoperative week
|
first postoperative week
|
|
plasma total antioxidant capacity (TAOC)
Tidsramme: 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
Tidsramme: 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
Tidsramme: first postoperative week
|
change between baseline and 1 week of: CRP, fibrinogen, WBC
|
first postoperative week
|
adverse events
Tidsramme: first postoperative week
|
first postoperative week
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Thomas Dietrich, DMD, MD, MPH, University of Birmingham
- Hovedetterforsker: Iain Chapple, BDS, PhD, Unversity of Birmingham
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RG_09-111
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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