An interventional study of Resin cement and Glass-ionomer cement in Healthy Adult Participants and Tooth Fracture, sponsored by Malmö University. Enrolling by invitation at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Malmö University · Not applicable, Interventional, and Treatment
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:
Researchers will compare zirconia crowns cemented with either a glass ionomer cement or a resin cement to evaluate differences in clinical outcomes.
Participants will:
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.
37 studies on the registry are indexed under Tooth Fractures; 9 are open to participants now.
This study's planned enrollment of 110 is above the median of 40 across 33 interventional studies indexed under Tooth Fractures.
Browse Tooth Fractures studies →Malmö University is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Tooth-supported zirconia crowns cemented with a resin-based cement
Other: Resin cement
Tooth-supported zirconia crowns cemented with a glass-ionomer cement
Other: Glass-ionomer cement
Zirconia crowns cemented with resin cement
Zirconia crowns cemented with glass-ionomer cement
Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up
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.
Time frame: Baseline and 1 year.
Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up
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.
Time frame: Baseline and 3 years.
Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up
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.
Time frame: Baseline and 5 years.
Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up
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.
Time frame: Baseline and 10 years.
Change from Baseline in "Patient-reported Outcome Measurement" at 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.
Time frame: Baseline and 1 year.
Change from Baseline in "Patient-reported Outcome Measurement" at 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.
Time frame: Baseline and 3 year.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jul 2028, 25 months after the start.
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Malmö University