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A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive

25 de abril de 2018 actualizado por: GlaxoSmithKline

A Proof of Principle Bite Force Study Using Two New Test Adhesives and a Currently Marketed Denture Adhesive.

The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite force study will be to compare bite force measurements over a 12 hour period across two (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control.

Descripción general del estudio

Descripción detallada

This will be a 4-treatment, 4-period, randomized, crossover, proof of principle bite force study which will compare bite force measurements over a 12 hour period across two cream denture adhesives with a currently marketed cream denture adhesive (positive control), and a negative/no treatment control. A short questionnaire regarding the flavor and texture characteristics of each denture adhesive after a single use will also be administered to give an indication of participant satisfaction of these attributes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

25

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

    • New Jersey
      • Bloomfield, New Jersey, Estados Unidos, 07003
        • 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

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  • Aged between 18 to 85 years.
  • Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination and absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements.
  • Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture. Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. Maxillary dentures must be considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan Modification: retention score >=2, stability score >=2). Maxillary dentures and mandibular dentures, if present, must be considered to be well-made based on design and construction criteria specified in the protocol. The qualifying maxillary incisal bite force readings (without adhesive) must be less than or equal to 9 pounds (lb) at the Screening Visit and subsequent visit pre-treatment baseline bites. At least 2 of the 4 qualifying bite readings at the Screening Visit must be reproducible (+/- 2lb). At subsequent visits the bite force readings must be within +/-2lb for 1 of the 3 practice bites and the pre-treatment baseline bite.
  • Understands and is willing, able and likely to comply with all study procedures and restrictions.

Exclusion Criteria:

  • A woman who is known to be pregnant or who is intending to become pregnant (self reported) over the duration of the study.
  • A woman who is breast-feeding.
  • Implanted with a cardiac pacemaker.
  • Daily doses of medication that might interfere with the ability to perform the study according to protocol (as determined by the Investigator).
  • Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
  • A serious chronic disease requiring hospitalization.
  • Any condition not previously mentioned that in the Investigator's opinion may impair the study evaluation.
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the participant's participation in the study.
  • Any participant clinically identified as having an incisal bite relation which could affect the bite force measurements.
  • Severe dry mouth that may affect denture retention in the opinion of the Investigator.
  • OST examination findings such as stomatitis, open sores, lesions, redness or swelling that, in the opinion of the investigator, could affect the participant's participation in the study.
  • Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
  • Previous participation in this study.
  • Recent history (within the last year) of alcohol or other substance abuse.
  • A participant who is unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of screening and each treatment day (12-14 hours).
  • An employee of the sponsor or the study site or members of their immediate family.

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Test Product 1
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
Test adhesive 1 with a thin nozzle
Experimental: Test Product 2
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
Test adhesive 2 with a thin nozzle
Comparador activo: Reference Product
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
Adhesive Cream
Otro: Negative Control
No adhesive

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
Periodo de tiempo: up to 12 hours
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive
Periodo de tiempo: up to 12 hours
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
up to 12 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
Periodo de tiempo: up to 12 hours
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive
Periodo de tiempo: up to 12 hours
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
up to 12 hours
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2
Periodo de tiempo: up to 12 hours
Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
up to 12 hours

Colaboradores e Investigadores

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

Patrocinador

Publicaciones y enlaces útiles

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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)

7 de marzo de 2017

Finalización primaria (Actual)

5 de abril de 2017

Finalización del estudio (Actual)

5 de abril de 2017

Fechas de registro del estudio

Enviado por primera vez

17 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

17 de octubre de 2016

Publicado por primera vez (Estimar)

19 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de mayo de 2018

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

25 de abril de 2018

Última verificación

1 de febrero de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 206233

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

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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