Dental CrownsPhase 4NCT02758457
Zirconia and Metal-based Single Crown Posterior Restorations.
A Phase 4 study testing dental crowns in people with Dental Crowns and Dental Prosthesis, run by University of Bologna at 1 site in Italy.
Trial summary
The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Crowns, Dental Prosthesis, Prosthodontics
- What is being tested?
- dental crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Male and female patients from 18-70 years of age
- Need for a single crown restoration
- Presence of antagonist
- minimum of 20 teeth
- moderate to good oral hygiene with the ability to perform mechanical oral hygiene techniques including tooth brushing
- low to moderate caries risk, and no active periodontal disease.
Who cannot join
- Women who are pregnant at the date of inclusion
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Smoking more than 15 cigarettes a day
- Poor oral hygiene (Plaque Index over 30%)
- Bruxism
- vital teeth
- allergic reaction or hypersensitivity to ingredients of the adhesive or restorative material
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation
Bologna, 40125
About this study
Official title: Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.
The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.
- Conditions
- Dental Crowns, Dental Prosthesis, Prosthodontics
- Being tested
- dental crowns
- Keywords
- cad/cam, dental porcelain, zirconia, press on metal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental crownsDevice
| Study group | Role | What they receive |
|---|---|---|
| metal-based restorations | Active comparator | single crown with a metal framework and pressed ceramic Receives: Device: dental crowns |
| zirconia-based restorations | Experimental | single crown with a zirconia framework and pressed ceramic Receives: Device: dental crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical complication rate
assessed by USPHS-criteria
Measured: 5 years
Secondary outcomes (2)
Survival rate
assessed by bleeding on probing
Measured: 1, 3, 5 years
Survival rate
pocket probing depth
Measured: 1, 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CrownsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, carlo monaco, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758457
- Sponsor's protocol ID
- 222893
- Status last verified
- Apr 2016
- First submitted
- 23 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Monaco C, Llukacej A, Baldissara P, Arena A, Scotti R. Zirconia-based versus metal-based single crowns veneered with overpressing ceramic for restoration of posterior endodontically treated teeth: 5-year results of a randomized controlled clinical study. J Dent. 2017 Oct;65:56-63. doi: 10.1016/j.jdent.2017.07.004. Epub 2017 Jul 21.
PubMed 28736293
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT02758457
- Acronym / sponsor ID
- 222893
- Conditions
- Dental Crowns, Dental Prosthesis, Prosthodontics
- Keywords
- cad/cam, dental porcelain, zirconia, press on metal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 May 2016 (estimated)
- 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 objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metal-based restorations | Active comparator | Device: dental crownssingle crown with a metal framework and pressed ceramic |
| zirconia-based restorations | Experimental | Device: dental crownssingle crown with a zirconia framework and pressed ceramic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed Consent as documented by signature
- Male and female patients from 18-70 years of age
- Need for a single crown restoration
- Presence of antagonist
- minimum of 20 teeth
Key exclusion criteria (8 listed)
- Women who are pregnant at the date of inclusion
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Smoking more than 15 cigarettes a day
- Poor oral hygiene (Plaque Index over 30%)
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 |
|---|---|---|
| dental crowns | Device | metal-based restorations, zirconia-based restorations |
Primary outcome
Technical complication rate
Time frame: 5 years
assessed by USPHS-criteria
2 secondary outcomes
Survival rate
Time frame: 1, 3, 5 years
Survival rate
Time frame: 1, 3, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Derived from this study: PubMed 28736293Monaco C, Llukacej A, Baldissara P, Arena A, Scotti R. Zirconia-based versus metal-based single crowns veneered with overpressing ceramic for restoration of posterior endodontically treated teeth: 5-year results of a randomized controlled clinical study. J Dent. 2017 Oct;65:56-63. doi: 10.1016/j.jdent.2017.07.004. Epub 2017 Jul 21.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dental crowns in people with Dental Crowns and Dental Prosthesis, run by University of Bologna at 1 site in Italy.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical complication rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758457, which also lists 1 linked publication.
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 2 May 2016.