Healthy Adult ParticipantsNCT07644676
The Impact of Adhesion Strategy on the Clinical Performance Of Indirect Dental Restorations
A study testing Resin cement and Glass-ionomer cement in people with Healthy Adult Participants and Tooth Fracture, run by Malmö University at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Adult Participants, Tooth Fracture
- What is being tested?
- Resin cement and Glass-ionomer cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jun 2026to Jun 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need of one single crown on vital posterior tooth
- Speak and understand Swedish language
- Free from dental/oral disease; caries, periodontal disease
Who cannot join
- Only individuals who do not meet the inclusion criteria will be excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Sandin Dentalklinik
Hörby, Skåne County
Tandläkare Le
Malmö, Skåne County, 21118
About this study
Official title: 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?
Read more
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
Read the detailed description
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.
- Conditions
- Healthy Adult Participants, Tooth Fracture
- Being tested
- Resin cement, Glass-ionomer cement
- Keywords
- crown, zirconia, dental cement, clinical trial
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin cementOther
Zirconia crowns cemented with resin cement
Glass-ionomer cementOther
Zirconia crowns cemented with glass-ionomer cement
| Study group | Role | What they receive |
|---|---|---|
| Resin cement | Active comparator | Tooth-supported zirconia crowns cemented with a resin-based cement Receives: Other: Resin cement |
| Glass-ionomer cement | Active comparator | Tooth-supported zirconia crowns cemented with a glass-ionomer cement Receives: Other: Glass-ionomer cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 10 years.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jun 2026
- Primary completionJul 2028 (estimated)
- Study completionJun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christel Larsson, Ph.D., Principal investigator, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644676
- Sponsor's protocol ID
- 2026-03170-01
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07644676
- Acronym / sponsor ID
- 2026-03170-01
- Conditions
- Healthy Adult Participants, Tooth Fracture
- Keywords
- crown, zirconia, dental cement, clinical trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jun 2036 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin cement | Active comparator | Other: Resin cementTooth-supported zirconia crowns cemented with a resin-based cement |
| Glass-ionomer cement | Active comparator | Other: Glass-ionomer cementTooth-supported zirconia crowns cemented with a glass-ionomer cement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Need of one single crown on vital posterior tooth
- Speak and understand Swedish language
- Free from dental/oral disease; caries, periodontal disease
Key exclusion criteria (1 listed)
- Only individuals who do not meet the inclusion criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resin cementZirconia crowns cemented with resin cement | Other | Resin cement |
| Glass-ionomer cementZirconia crowns cemented with glass-ionomer cement | Other | Glass-ionomer cement |
Primary outcome
Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up
Time frame: 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.
Clinical outcome of tooth-supported zirconia crowns from baseline to 3-year follow up
Time frame: 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.
Clinical outcome of tooth-supported zirconia crowns from baseline to 5-year follow up
Time frame: 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.
Clinical outcome of tooth-supported zirconia crowns from baseline to 10-year follow up
Time frame: 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.
2 secondary outcomes
Change from Baseline in "Patient-reported Outcome Measurement" at 1 year
Time frame: Baseline and 1 year.
Change from Baseline in "Patient-reported Outcome Measurement" at 3 year
Time frame: Baseline and 3 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christel Larsson, Ph.D. principal investigator
Malmö University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin cement and Glass-ionomer cement in people with Healthy Adult Participants and Tooth Fracture, run by Malmö University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome of tooth-supported zirconia crowns from baseline to 1-year follow up (time frame: Baseline and 1 year.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.