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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Skåne County
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Hörby, Skåne County, Suecia
- Sandin Dentalklinik
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Malmö, Skåne County, Suecia, 21118
- Tandläkare Le
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Resin cement
Tooth-supported zirconia crowns cemented with a resin-based cement
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Zirconia crowns cemented with resin cement
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Comparador activo: Glass-ionomer cement
Tooth-supported zirconia crowns cemented with a glass-ionomer cement
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Zirconia crowns cemented with glass-ionomer cement
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up
Periodo de tiempo: Baseline and 1 year.
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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.
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Baseline and 1 year.
|
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Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up
Periodo de tiempo: 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.
|
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Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up
Periodo de tiempo: 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.
|
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Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in "Patient-reported Outcome Measurement" at 1 year
Periodo de tiempo: 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.
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Baseline and 1 year.
|
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Change from Baseline in "Patient-reported Outcome Measurement" at 3 year
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Estomatognáticas
- Heridas y Lesiones
- Enfermedades de los dientes
- Lesiones dentales
- Fracturas dentales
- Polímeros
- Sustancias macromoleculares
- Materiales biomédicos y dentales
- Materiales manufacturados
- Tecnología, industria y agricultura
- Plástica
- Resinas, sintéticas
- Cementos dentales
- Materiales dentales
- Cementos de resina
- Cementos de ionómero de vidrio
Otros números de identificación del estudio
- 2026-03170-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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