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Efficacy of Three Toothpastes Using an in Situ Caries Model

11 de octubre de 2017 actualizado por: GlaxoSmithKline

Clinical Efficacy of Three Experimental Toothpastes Using an in Situ Caries Model

This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

58

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

  • Estados Unidos
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • GSK Investigational Site

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 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Demonstrates understanding of the study.
  2. Aged 18 to 85 years.
  3. Understands and is willing, able and likely to comply with all study procedures and restrictions.
  4. Has good general health (in the opinion of the investigator or medically qualified designee).
  5. A salivary flow-rate in the range of normal values (unstimulated whole saliva flow- Rate ≥ 0.2 g/minute (min); gum base stimulated whole saliva flow-Rate ≥ 0.8 g/min).
  6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
  7. Have no current active caries or periodontal disease and all restorations in a good state of repair.
  8. Willing and capable of brushing their natural teeth with the lower partial denture in place.

Exclusion Criteria:

  1. Pregnant or breast feeding women.
  2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
  3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
  4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
  5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
  7. Recent history (within the last year) of alcohol or other substance abuse.

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

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental Dentifrice1
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
Droga: 0.425 % w/w phytate,1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
Experimental: Experimental Dentifrice 2
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
Droga: 0.85 % w/w phytate,1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
Experimental: Experimental Dentifrice 3
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
Droga: 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
Comparador de placebos: Reference Product 1
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
Otro: 0 ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
Comparador activo: Reference Product 2
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
Droga: 1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
Comparador activo: Reference Product 3
Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.
Droga: 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks
Periodo de tiempo: Baseline upto 2 weeks
SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.
Baseline upto 2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
% SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate
Periodo de tiempo: Baseline upto 2 weeks
SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.
Baseline upto 2 weeks
Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks
Periodo de tiempo: Baseline upto 4 weeks
TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).
Baseline upto 4 weeks
TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate
Periodo de tiempo: Baseline upto 4 weeks
TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).
Baseline upto 4 weeks
Enamel Fluoride Uptake (EFU) of All Study Formulation Variables
Periodo de tiempo: At Week 2
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.
At Week 2
Enamel Fluoride Uptake (EFU) of All Study Formulation Variables
Periodo de tiempo: At Week 4
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.
At Week 4

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

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 (Actual)

1 de febrero de 2016

Finalización primaria (Actual)

1 de julio de 2016

Finalización del estudio (Actual)

11 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2016

Primero enviado que cumplió con los criterios de control de calidad

21 de abril de 2016

Publicado por primera vez (Estimar)

26 de abril de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

11 de octubre de 2017

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 202301

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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