Partial EdentulismNCT02188212
Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD
A study testing NobelProcera Crown Shaded Zirconia in people with Partial Edentulism, run by Nobel Biocare at 1 site in Germany.
Trial summary
Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70 years, provided they fulfill the inclusion criteria and need two single tooth restorations on contralateral teeth in the same arch. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- NobelProcera Crown Shaded Zirconia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Jul 2014
- 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
- Healthy volunteers accepted
- 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.
About this study
Official title: A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProceraTM Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD on Molars
Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70 years, provided they fulfill the inclusion criteria and need two single tooth restorations on contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium disilicate on the 1st or 2nd molar randomly allocated to the same tooth position contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as possible adverse events, will be carefully monitored during the entire investigation period.
- Conditions
- Partial Edentulism
- Being tested
- NobelProcera Crown Shaded Zirconia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobelProcera Crown Shaded ZirconiaDevice
| Study group | Role | What they receive |
|---|---|---|
| NobelProcera Crown Shaded Zirconia | Other | NobelProcera Crown Shaded Zirconia molar Receives: Device: NobelProcera Crown Shaded Zirconia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the longevity 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.
Measured: yearly up to 5 years
Secondary outcomes (1)
Clinical behaviour (CDA Index, soft tissue behavior) 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.
Measured: yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMar 2010
- Primary completionNov 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Wolfarth, Prof, Principal investigator, University of Aachen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188212
- Sponsor's protocol ID
- T-158
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProceraTM Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD on Molars
- ClinicalTrials.gov ID
- NCT02188212
- Acronym / sponsor ID
- T-158
- Conditions
- Partial Edentulism
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Jul 2014 (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.
Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70 years, provided they fulfill the inclusion criteria and need two single tooth restorations on contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium disilicate on the 1st or 2nd molar randomly allocated to the same tooth position contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as possible adverse events, will be carefully monitored during the entire investigation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NobelProcera Crown Shaded Zirconia | Other | Device: NobelProcera Crown Shaded ZirconiaNobelProcera Crown Shaded Zirconia molar |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| NobelProcera Crown Shaded Zirconia | Device | NobelProcera Crown Shaded Zirconia |
Primary outcome
To compare the longevity 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.
Time frame: yearly up to 5 years
1 secondary outcome
Clinical behaviour (CDA Index, soft tissue behavior) 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.
Time frame: yearly up to 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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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.
Stefan Wolfarth, Prof principal investigator
University of Aachen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NobelProcera Crown Shaded Zirconia in people with Partial Edentulism, run by Nobel Biocare at 1 site in Germany.
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: stopped early, as of the sponsor's last update on 3 Mar 2021. 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 Germany. 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?
The study was stopped early. 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?
To compare the longevity 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. (time frame: yearly up to 5 years). 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 3 Mar 2021.