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- Ensaio Clínico NCT04543604
Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis
Understanding, Modulation and Memorization of Indicators Associated to Peri-implantitis: A Randomized Controlled Trial
Communication strategies are encouraged to enhance patients´ understanding of potential events related to implant therapy such as peri-implantitis. Moreover, it is key to provide accurate information to patients receiving dental implants to reduce false expectations and to minimize the alterations concerning satisfaction. Information leaflets based in the "health-belief model" proved efficiency in improving health judgments, decisions and behaviors, in particular when supplemented with visual aids. Hence, it was the purpose of the present study to test the effectiveness of different communication strategies to enhance and modulate the understanding and memorization of risk indicators associated to peri-implantitis.
A prospective randomized controlled three-arm study is being conducted in accordance with the Declaration of Helsinki on human studies. Three groups are defined to test the hypothesis that visual aids improve the understanding, modulation and memorization of peri-implantitis and related indicators as follows:
- Test group1 - Leaflet with visual aid (L-VA): Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included (supplementary figure 1). Relevant scientific bibliography supported the statements. Along, pictograms were supplemented to display the prevalence of disease with and without the known indicator.
- Test group2 - Leaflet with visual aid (L-NVA): Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included (supplementary figure 2). Relevant scientific bibliography supported the statements. No pictograms were supplemented.
- Control group - No leaflet (NL): Only verbal information was provided to the patient during initial interview.
Patients will be randomly assigned to the tests or control groups according to the last digit of their chart number. As such, patients with records ending 1-4, 4-7 and 8-0 were included in test group1, test group2 and control group, respectively. When reached the total sample size of any of the groups, patients were only recruited for the remaining groups to complete the total sample size. A questionnaire based on the "health-belief model" will be collected from every eligible patient at baseline, 3- and 6-month follow-up
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Badajoz, Espanha, 06011
- Centro de Implantologia Cirugia Oral y Maxilofacial
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Test group1 - Leaflet with visual aid
Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included.
Relevant scientific bibliography supported the statements.
Along, pictograms were supplemented to display the prevalence of disease with and without the known indicator.
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The questionnaires were collected at baseline (at the end of the initial interview and once the patients assigned within the test groups declared to have read the leaflet) at 3- and 6-month follow-up.
The questionnaire included demographic data such as age, gender, civil status, occupation (coded according to the CNO-11(2010), presence of systemic disorder, smoking and number of implants.
Moreover, data concerning history of periodontal disease and type of prosthesis were further documented and added to demographics.
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Experimental: Test group2 - Leaflet with visual aid (L-NVA)
Information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included.
Relevant scientific bibliography supported the statements.
No pictograms were supplemented.
|
The questionnaires were collected at baseline (at the end of the initial interview and once the patients assigned within the test groups declared to have read the leaflet) at 3- and 6-month follow-up.
The questionnaire included demographic data such as age, gender, civil status, occupation (coded according to the CNO-11(2010), presence of systemic disorder, smoking and number of implants.
Moreover, data concerning history of periodontal disease and type of prosthesis were further documented and added to demographics.
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Sem intervenção: • Control group - No leaflet (NL)
Only verbal information was provided to the patient during initial interview.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Understanding
Prazo: Baseline
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Questionnaire
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Baseline
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Memorisation
Prazo: 3 month follow-up
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Questionnaire
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3 month follow-up
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Memorisation
Prazo: 6 month follow-up
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Questionnaire
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6 month follow-up
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Colaboradores e Investigadores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 18002909-18/9/19
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Peri-implantite
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Istanbul Medipol University HospitalAnkara University; Ankara Medipol University; Lokman Hekim UniversityConcluídoPeri Implantite | Saúde peri-implantar | Mucosite peri-implantarTurquia (Türkiye)
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Chang Gung Memorial HospitalConcluídoNível ósseo peri-implantar | Saúde peri-implantar | Tecidos Peri-ImplantaresTaiwan
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King Abdullah University HospitalJordan University of Science and TechnologyConcluídoPeri-implantite e mucosite peri-implantarJordânia
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Recep Tayyip Erdogan UniversityAinda não está recrutandoPeri Implantite | Mucosite peri-implantar
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University of BarcelonaInstitut d'Investigació Biomèdica de BellvitgeAinda não está recrutandoMucosite peri-implantar | Saúde peri-implantar
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Abant Izzet Baysal UniversityConcluídoPeri-implantite | Mucosite peri-implantar | Saúde peri-implantarTurquia (Türkiye)
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Kutahya Health Sciences UniversityAinda não está recrutandoAvaliação Clínica, Radiográfica e Digital dos Efeitos dos Enxertos Autógenos na Mucosa Peri-implanteMucosite peri-implantar | Saúde peri-implantar | Enxerto Gengival GratuitoTurquia (Türkiye)
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University of CagliariConcluídoPerda óssea peri-implantar | Tecidos Peri-ImplantaresItália
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University of CataniaConcluídoInflamação peri-implantar | Peri-implantite | Saúde peri-implantar | Mucosite Peri-ImplanteItália
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Pamukkale UniversityPamukkale University scientific research project departmentConcluídoPerda óssea marginal | Perda óssea marginal peri-implantar | Perda óssea peri-implantar | Saúde peri-implantarTurquia (Türkiye)