SuccessNCT01835821
Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns
A study testing prosthetic crowns in people with Success and Survival, run by University of Siena at 1 site in Italy.
Trial summary
This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- prosthetic crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Mar 2016
- Phase
- Interventional
- 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
- The subject must be at least 18 (or age of consent) and less than 70 at the time of inclusion.
- The subject is healthy and compliant with good oral hygiene.
- The subject is in need of at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject.
- No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
- Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
- The subject is available for the 5-year term of the investigation.
Who cannot join
- The subject is not able to give her/his informed consent to participate.
- Alcohol or drug abuse as noted in patient records or in patient history.
- Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
- An existing condition where acceptable retention of the restoration is impossible to attain
- Mobility of the tooth to be restored.
- Pathologic pocket formation of 4 mm or greater around the tooth to be restored.
Show all 9Show fewer
- Severe bruxism or other destructive habits.
- Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
- Health conditions, which do not permit the restorative procedure.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena, Siena, Italy
Siena, SI, 53100
About this study
Official title: A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProcera(TM) Crown Shaded Zirconia and NobelProcera(TM) Full Contour Crown IPS e.Max CAD on Molars
This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.
- Being tested
- prosthetic crowns
- Keywords
- zirconia, crown, IPS e.max CAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthetic crownsDevice
prosthetic crowns
| Study group | Role | What they receive |
|---|---|---|
| prosthesis | Experimental | NobelProcera™ Crown shaded zirconia:
The device is an individual, ceramic core (figure a) made of shaded zirconium with an anatomic contour providing homogenous veneering material thickness and a minimum core thickness of 0.4 or 0.7mm. The core is veneered with dental porcelain (IPS e.max Ceram) at the dental laboratory Receives: Device: prosthetic crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of Porcelain-fused and IPS e.Max CAD Crowns
A "successful crown" is when the CDA index (Marginal integrity, Color match, Surface texture and Anatomic form) shall be Romeo or Sierra (excellent or acceptable) at delivery and remain so during the study period.
Measured: 5 years
Secondary outcomes (1)
survival of Porcelain-fused and IPS e.Max CAD Crowns
A "surviving crown" is when the crown remains in occlusion, and when the subject's treatment is functionally successful even though all the individual success criteria are not fulfilled.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startMar 2010
- Primary completionSep 2015 (estimated)
- Study completionMar 2016 (estimated)
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 SuccessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Marco Ferrari, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835821
- Sponsor's protocol ID
- T-158
- Other IDs
- T-158s
- Status last verified
- Jul 2014
- First submitted
- 5 Apr 2013
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cagidiaco EF, Grandini S, Goracci C, Joda T. A pilot trial on lithium disilicate partial crowns using a novel prosthodontic functional index for teeth (FIT). BMC Oral Health. 2019 Dec 9;19(1):276. doi: 10.1186/s12903-019-0957-4.
PubMed 31818278
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProcera(TM) Crown Shaded Zirconia and NobelProcera(TM) Full Contour Crown IPS e.Max CAD on Molars
- ClinicalTrials.gov ID
- NCT01835821
- Acronym / sponsor ID
- T-158
- Keywords
- zirconia, crown, IPS e.max CAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 19 Apr 2013 (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.
This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prosthesis | Experimental | Device: prosthetic crownsNobelProcera™ Crown shaded zirconia: The device is an individual, ceramic core (figure a) made of shaded zirconium with an anatomic contour providing homogenous veneering material thickness and a minimum core thickness of 0.4 or 0.7mm. The core is veneered with dental porcelain (IPS e.max Ceram) at the dental laboratory |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject must be at least 18 (or age of consent) and less than 70 at the time of inclusion.
- The subject is healthy and compliant with good oral hygiene.
- The subject is in need of at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject.
Key exclusion criteria (9 listed)
- The subject is not able to give her/his informed consent to participate.
- Alcohol or drug abuse as noted in patient records or in patient history.
- Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
- An existing condition where acceptable retention of the restoration is impossible to attain
- Mobility of the tooth to be restored.
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 |
|---|---|---|
| prosthetic crownsprosthetic crowns | Device | prosthesis |
Primary outcome
success of Porcelain-fused and IPS e.Max CAD Crowns
Time frame: 5 years
A "successful crown" is when the CDA index (Marginal integrity, Color match, Surface texture and Anatomic form) shall be Romeo or Sierra (excellent or acceptable) at delivery and remain so during the study period.
1 secondary outcome
survival of Porcelain-fused and IPS e.Max CAD Crowns
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Derived from this study: PubMed 31818278Cagidiaco EF, Grandini S, Goracci C, Joda T. A pilot trial on lithium disilicate partial crowns using a novel prosthodontic functional index for teeth (FIT). BMC Oral Health. 2019 Dec 9;19(1):276. doi: 10.1186/s12903-019-0957-4.
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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 study testing prosthetic crowns in people with Success and Survival, run by University of Siena 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Jul 2014. 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.
Are results available for this study?
Results are not available in the source record.
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?
success of Porcelain-fused and IPS e.Max CAD Crowns (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 NCT01835821, 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 8 Jul 2014.