- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01665911
An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy
3 de febrero de 2015 actualizado por: Frank Lippert
The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect.
Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The evidence of milk fluoridation as a public health measure in caries prevention has been demonstrated in many clinical studies.
While these data are encouraging, the main focus now should be on the optimization of milk fluoride programs.
This protocol will concentrate on the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral caries test or model (ICT).
The ICT is an established model which features the use of gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque stagnation area.
After subject has been consented and enrolled in the study per the inclusion/exclusion criteria, two to three days following a dental cleaning, two partially demineralized specimens will be placed in the buccal flange area of the subject's mandibular partial denture.
During each of the five, three-week test periods, subjects will drink their assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk) timed minutes, wearing their mandibular partial dentures 24 hours a day during the test period.
Fluoride free toothpaste will be used two to three days before and continuously during each treatment period.
After each three-week test period, the two partially demineralized specimens will be removed from the subject's partial denture and analyzed using the surface microhardness test.
Mineral content change (as percentage of surface microhardness recovery) in these artificially induced incipient enamel lesions will be the primary outcome variable.
Each subject (n = 28) will serve as his or her own control.
Tipo de estudio
Intervencionista
Inscripción (Actual)
28
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Oral Health Research Institute, Indiana University School of Dentistry
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- sign an informed consent, authorization for the release of health information for research and provide medical history information, including medications, prior to their participation;
- be between 18 and 80 years old and in general good health;
- willingness to use a reliable form of contraception or abstaining during the course of the study (females of child-bearing potential only)
- wear a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);
- be willing and capable of wearing their removable mandibular partial dentures 24 hours a day for a total of five, three-week test periods;
- be in good dental health with no active caries or periodontal disease;
- agree to comply with all subjects' responsibilities as stated in the protocol (e.g. use of study products, attendance at appointments, etc.);
- have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 ml/min; gum base stimulated whole saliva flow rate ≥ 0.8 ml/min).
- Be able to tolerate the taste and room temperature of the mixed milk product as demonstrated by drinking the milk at screening
Exclusion Criteria:
be pregnant, intending to become pregnant during the study period or breast feeding. A urine pregnancy test will be required at screening, the start of each treatment visit and the last study visit for all subjects of child-bearing potential to confirm the subject is not pregnant.
- have any medical condition that could be expected to interfere with the subject's safety during the study period;
- demonstrate an inability to comply with study procedures;
- have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. (*Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleanings, may be accepted into the study at the discretion of the Investigator.)
- be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
- be lactose intolerant or have known allergy or intolerance to milk or milk products
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Arm 1
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
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Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
|
Otro: Arm 2
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
|
Otro: Arm 3
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
|
Otro: Arm 4
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
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Comparador activo: Arm 5
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design
Otros nombres:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
Periodo de tiempo: Three Weeks per each of five arms
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Three Weeks per each of five arms
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
% Acid Resistance Score Per Each of Five Arms
Periodo de tiempo: Three Weeks per each of five arms
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% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.
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Three Weeks per each of five arms
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Enamel Fluoride Uptake Per Each of Five Arms
Periodo de tiempo: Three Weeks per each of five arms
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Enamel fluoride uptake is a measure of fluoridation of a caries lesion
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Three Weeks per each of five arms
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Domenick Zero, DDS, MS, Indiana University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2012
Finalización primaria (Actual)
1 de abril de 2013
Finalización del estudio (Actual)
1 de junio de 2013
Fechas de registro del estudio
Enviado por primera vez
7 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
13 de agosto de 2012
Publicado por primera vez (Estimar)
16 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de febrero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
3 de febrero de 2015
Última verificación
1 de febrero de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12-I-086
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. .