- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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West Midlands
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Birmingham, West Midlands, Reino Unido, B18 4DA
- University of Birmingham
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
|
Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
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Experimental: Jugo Plus
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Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quality of Life
Periodo de tiempo: first postoperative week
|
QOL as assessed by PoSSe scale (Ruta et al., 2000)
|
first postoperative week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
trismus
Periodo de tiempo: postoperative week
|
trismus will be assessed by investigator at 48h and 1 week postoperative, and every postop day by patient
|
postoperative week
|
postoperative pain
Periodo de tiempo: 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
Periodo de tiempo: first postoperative week
|
first postoperative week
|
|
plasma total antioxidant capacity (TAOC)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: first postoperative week
|
change between baseline and 1 week of: CRP, fibrinogen, WBC
|
first postoperative week
|
adverse events
Periodo de tiempo: first postoperative week
|
first postoperative week
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas Dietrich, DMD, MD, MPH, University of Birmingham
- Investigador principal: Iain Chapple, BDS, PhD, Unversity of Birmingham
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RG_09-111
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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