Missing TeethNCT01835834
Clinical Study on Zirconia Bridges
A study testing zirconia bridge restoration in people with Missing Teeth, run by University of Siena.
Trial summary
To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Missing Teeth
- What is being tested?
- zirconia bridge restoration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2015
- 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 a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject the subject should be available for the 5-year term of the investigation.
- 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 should be 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
About this study
To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.
- Conditions
- Missing Teeth
- Being tested
- zirconia bridge restoration
- Keywords
- zirconia crown
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zirconia bridge restorationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| zirconia bridge restoration | Experimental | The device is a ceramic core made of shaded zirconium with an anatomic contour core with a minimum of 0.6 mm thickness and minimal connector size of 4.0 x 3.0 / 9.4 (height x width [mm] / area [mm2]) of high strength zirconia framework providing homogenous veneering material thickness as an external coating with 1.0 - 2.0 mm* wall thickness. The core is veneered with dental porcelain at the dental laboratory.
Intended use and indications:
NobelProceraTM Bridge Shaded Zirconia consists of an individualized, supporting substructure in a ceramic bridge construction for tooth/teeth replacement.
NobelProceraTM Bridge Zirconia is intended for patients in need of prosthetic oral reconstruction in order to restore chewing function. Zirconia bridges for natural tooth restorations are customized, designed, and milled from pre-sintered blanks of zirconia. The multi-unit restorations can be placed in all positions in the mouth. Receives: Procedure: zirconia bridge restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate of NobelProcera™ Bridge Shaded Zirconia
Success and Failure Criteria The CDA index will be used for the success criteria in this investigation. Please see also the criteria in the "clinical parameter" part of this protocol.
The success and failure criteria to be used in this investigation have been determined as follows:
A successful NobelProcera™ Bridge Shaded Zirconia is when:
the CDA index is Romeo or Sierra at delivery and remains so during the study period.
A surviving NobelProcera™ Bridge Shaded Zirconia is when:
the restoration is in occlusion and in function, even though all the success criteria are not fulfilled, but is to be regarded as correctable.
A failed NobelProcera™ Bridge Shaded Zirconia is when:
the restoration has 1) been removed, 2) fractured, or 3) cannot be classified as a surviving or a successful restoration.
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 startJan 2010
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies 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
- 9 participants (actual)
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
- NCT01835834
- Sponsor's protocol ID
- T-159
- Status last verified
- Jul 2014
- First submitted
- 5 Apr 2013
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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
- Clinical Study on Zirconia Bridges
- ClinicalTrials.gov ID
- NCT01835834
- Acronym / sponsor ID
- T-159
- Conditions
- Missing Teeth
- Keywords
- zirconia crown
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (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.
To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zirconia bridge restoration | Experimental | Procedure: zirconia bridge restorationThe device is a ceramic core made of shaded zirconium with an anatomic contour core with a minimum of 0.6 mm thickness and minimal connector size of 4.0 x 3.0 / 9.4 (height x width [mm] / area [mm2]) of high strength zirconia framework providing homogenous veneering material thickness as an external coating with 1.0 - 2.0 mm* wall thickness. The core is veneered with dental porcelain at the dental laboratory. Intended use and indications: NobelProceraTM Bridge Shaded Zirconia consists of an individualized, supporting substructure in a ceramic bridge construction for tooth/teeth replacement. NobelProceraTM Bridge Zirconia is intended for patients in need of prosthetic oral reconstruction in order to restore chewing function. Zirconia bridges for natural tooth restorations are customized, designed, and milled from pre-sintered blanks of zirconia. The multi-unit restorations can be placed in all positions in the mouth. |
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 a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject the subject should be available for the 5-year term of the investigation.
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 |
|---|---|---|
| zirconia bridge restoration | Procedure or surgery | zirconia bridge restoration |
Primary outcome
survival rate of NobelProcera™ Bridge Shaded Zirconia
Time frame: 5 years
Success and Failure Criteria The CDA index will be used for the success criteria in this investigation. Please see also the criteria in the "clinical parameter" part of this protocol. The success and failure criteria to be used in this investigation have been determined as follows: A successful NobelProcera™ Bridge Shaded Zirconia is when: the CDA index is Romeo or Sierra at delivery and remains so during the study period. A surviving NobelProcera™ Bridge Shaded Zirconia is when: the restoration is in occlusion and in function, even though all the success criteria are not fulfilled, but is to be regarded as correctable. A failed NobelProcera™ Bridge Shaded Zirconia is when: the restoration has 1) been removed, 2) fractured, or 3) cannot be classified as a surviving or a successful restoration.
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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing zirconia bridge restoration in people with Missing Teeth, run by University of Siena.
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.
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?
survival rate of NobelProcera™ Bridge Shaded Zirconia (time frame: 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 8 Jul 2014.