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

25 de abril de 2018 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

25

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • New Jersey
      • Bloomfield, New Jersey, Estados Unidos, 07003
        • GSK Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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 Ativo: Reference Product
Applied topically to upper denture, to clean dry denture fit surface in a pattern consistent with application instructions.
Adhesive Cream
Outro: Negative Control
No adhesive

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de março de 2017

Conclusão Primária (Real)

5 de abril de 2017

Conclusão do estudo (Real)

5 de abril de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

17 de outubro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de outubro de 2016

Primeira postagem (Estimativa)

19 de outubro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de maio de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de abril de 2018

Última verificação

1 de fevereiro de 2018

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 206233

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

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