The Impact of Adhesion Strategy on the Clinical Performance Of Indirect Dental Restorations
The Influence of Cement Systems on the Outcome of Tooth Supported Zirconia Crowns in the Posterior Region: a Randomized ,Multicenter, and Practice-based Clinical Trial
The goal of this clinical trial is to evaluate whether different cement systems influence the clinical outcome of posterior tooth supported zirconia crowns in adult patients requiring single crown restorations. The main questions it aims to answer are:
- Do glass ionomer cements provide clinical outcomes comparable to those of resin cements for posterior zirconia crowns?
- Do marginal discoloration, marginal integrity, and biological complications differ between the cement systems?
- Do patient reported and clinician reported outcomes differ between the cementation procedures?
Researchers will compare zirconia crowns cemented with either a glass ionomer cement or a resin cement to evaluate differences in clinical outcomes.
Participants will:
- Receive posterior zirconia crowns fabricated according to standardized clinical procedures
- Be randomized to cementation with either a glass ionomer cement or a resin cement
- Undergo clinical examinations assessing crown survival, marginal adaptation, discoloration, caries, periodontal status, and wear
- Complete questionnaires regarding patient comfort and treatment experience
- Attend baseline and annual follow-up examinations for up to 10 years
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tooth damage has significant impact on a person's quality of life and damaged teeth should be treated to restore lost functions and prevent further damage. Loss of tooth substance can be restored by a direct (filling) or indirect restoration (artificial crown). These interventions differ in some operative aspects but share key challenges, particularly in achieving optimal adhesion to tooth substance to secure predictable retention and the integrity of the marginal seal.
Failure of the adhesive interface is a major determinant of restoration longevity and may manifest across patient-centered, biological, and technical outcomes.
Marginal degradation may result in discoloration, representing an early clinical indicator of interface breakdown that negatively affects patient satisfaction and may lead to a need for retreatment. Progressive marginal leakage facilitates bacterial access, increasing the risk of biological complications such as secondary caries and pulpal involvement.
Loss of retention represents a major technical complication, often requiring replacement of the restoration and contributing to cumulative loss of tooth structure over time.
Despite advances in restorative materials and adhesive systems, clinical outcomes remain variable, and the relative contribution of material properties, procedural complexity, and biological factors to long-term failure is not fully understood. In particular, the role of technique sensitivity and procedural complexity as independent determinants of restoration survival remains insufficiently characterized. Improved understanding of these interacting factors will enable more precise selection of restorative materials and cementation strategies.
This project will: (a) identify and quantify clinically relevant determinants of restoration failure, enabling improved prediction of restoration survival and patient satisfaction, (b) elucidate how interfacial degradation and technique sensitivity contribute to biological and technical complications, (c) aid clinical decision-making by guiding selection of materials and procedures based on their performance and complexity.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Skåne County
-
Hörby, Skåne County, Suécia
- Sandin Dentalklinik
-
Malmö, Skåne County, Suécia, 21118
- Tandläkare Le
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Need of one single crown on vital posterior tooth
- Speak and understand Swedish language
- Free from dental/oral disease; caries, periodontal disease
Exclusion Criteria:
- Only individuals who do not meet the inclusion criteria will be excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Resin cement
Tooth-supported zirconia crowns cemented with a resin-based cement
|
Zirconia crowns cemented with resin cement
|
|
Comparador Ativo: Glass-ionomer cement
Tooth-supported zirconia crowns cemented with a glass-ionomer cement
|
Zirconia crowns cemented with glass-ionomer cement
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up
Prazo: Baseline and 1 year.
|
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
|
Baseline and 1 year.
|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up
Prazo: Baseline and 3 years.
|
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
|
Baseline and 3 years.
|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up
Prazo: Baseline and 5 years.
|
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
|
Baseline and 5 years.
|
|
Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up
Prazo: Baseline and 10 years.
|
Clinical performance of tooth supported zirconia crowns assessed using modified CDA criteria, including survival, success, biological complications, technical complications, marginal integrity, discoloration, and surface morphology.
|
Baseline and 10 years.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in "Patient-reported Outcome Measurement" at 1 year
Prazo: Baseline and 1 year.
|
Patient reported and operator reported outcomes will be assessed using structured questionnaires evaluating treatment comfort, clinical handling, and overall satisfaction.
Questionnaire scores range from 1 to 5, where higher scores indicate greater satisfaction and improved treatment experience.
|
Baseline and 1 year.
|
|
Change from Baseline in "Patient-reported Outcome Measurement" at 3 year
Prazo: Baseline and 3 year.
|
Patient reported and operator reported outcomes will be assessed using structured questionnaires evaluating treatment comfort, clinical handling, and overall satisfaction.
Questionnaire scores range from 1 to 5, where higher scores indicate greater satisfaction and improved treatment experience.
|
Baseline and 3 year.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christel Larsson, Ph.D., Malmö University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças estomatognáticas
- Ferimentos e Lesões
- Doenças de dente
- Lesões Dentárias
- Fraturas Dentes
- Polímeros
- Substâncias macromoleculares
- Materiais biomédicos e dentários
- Materiais fabricados
- Tecnologia, indústria e agricultura
- Plásticos
- Resinas, sintéticas
- Cimentos dentários
- Materiais dentários
- Cimentos de resina
- Cimentos de ionômero de vidro
Outros números de identificação do estudo
- 2026-03170-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .