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- Ensaio Clínico NCT01665911
An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy
3 de fevereiro de 2015 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
28
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
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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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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 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
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
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Outro: 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
|
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
|
Outro: 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.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
|
Outro: 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.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
|
Outro: 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.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
|
Comparador Ativo: 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.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design
Outros nomes:
Each subject will use this product during one of the five treatment periods in the crossover study design.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
Prazo: Three Weeks per each of five arms
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Three Weeks per each of five arms
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
% Acid Resistance Score Per Each of Five Arms
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Domenick Zero, DDS, MS, Indiana University
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
1 de agosto de 2012
Conclusão Primária (Real)
1 de abril de 2013
Conclusão do estudo (Real)
1 de junho de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
7 de agosto de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de agosto de 2012
Primeira postagem (Estimativa)
16 de agosto de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
23 de fevereiro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de fevereiro de 2015
Última verificação
1 de fevereiro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12-I-086
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