Partial EdentulismNCT04166695
Clinical Performance of Long-span Fixed Partial Dentures
A study testing Monolithic / facially veneered zirconia fixed partial denture and Completely veneered CoCr fixed partial denture in people with Partial Edentulism, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Tooth-coloured fixed restorations are becoming increasingly popular with patients and dentists. If high-strength all-ceramics such as zirconia are used as the restoration material, a maximum of two adjacent missing teeth can be replaced with the aid of fixed partial dentures (FPDs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- Monolithic / facially veneered zirconia fixed partial denture and Completely veneered CoCr fixed partial denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jan 2020to Jan 2027
- 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
- The patient is at least 18 years old.
- The patient has unrestricted legal capacity.
- The patient has two posterior teeth (premolars and / or molars) that are to be replaced next to each other.
- The patient is reliable and willing to take part in follow-up examinations regularly and over the entire study period (three years).
- The information about the study has been understood by the patient and the signed declaration of consent has been received.
Who cannot join
- Pregnancy and lactation
- Local and / or systemic acute and / or chronic (also in the past) general medical diseases and conditions that contradict participation in the study and / or expose the patient to a higher risk in the case of participation in the study.
- Severe bruxism diagnosed by a portable electrocardiomyography device (BruxOff) (> 4 bruxism episodes / night)
- Reduced clinical crown height (< 5 mm before tooth preparation)
- Limited periodontal health:
- probing depths > 4 mm or = 4 mm and bleeding on probing,
Show all 15Show fewer
- Furcation involvement > I (first band of the periodontometer after Naber disappears completely)
- Degree of loosening of the abutment teeth > Grade I (> 1 mm horizontal mobility)
- Untreated endodontic problems of abutment teeth
- Lack of antagonistic support from fixed dentures or natural teeth
- Known allergies or intolerances to the materials used in the study
- Lack of oral hygiene
- Lack of compliance
- Planned change of residence
- Rejection of randomisation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Wolfgang Bömicke, PD Dr. MSc., +496221566052, Wolfgang.Boemicke@med.uni-heidelberg.de
About this study
Official title: Clinical Performance of Long-span All-ceramic or Metal-ceramic Fixed Partial Dentures on Implants and/or Natural Teeth
Tooth-coloured fixed restorations are becoming increasingly popular with patients and dentists. If high-strength all-ceramics such as zirconia are used as the restoration material, a maximum of two adjacent missing teeth can be replaced with the aid of fixed partial dentures (FPDs). For the replacement of a missing anterior or posterior tooth by FPDs, a very good clinical performance similar to that of metal-based, ceramic-veneered restorations can be expected. However, evidence-based statements on the clinical performance of long-span all-ceramic FPDs are difficult because there are only very few studies on this topic, which are also inhomogeneous with regard to the study conditions. Randomized studies to compare monolithic (consisting only of the high-strength framework material) or partially veneered (weaker veneering ceramics in esthetically relevant tooth areas) all-ceramic and classic (completely veneered) metal-ceramic FPDs are lacking. The aim of the current explorative, prospective, randomized, two-arm clinical interventional study is therefore to compare the clinical performance of long-span FPDs (≥ 4 Pontics) made of monolithic / facially veneered zirconium dioxide with a gold standard (completely veneered cobalt chromium (CoCr)-based FPDs). Forty patients will be recruited. Once all inclusion criteria have been established, including the signed informed consent of the patients informed of the content, effort, advantages and disadvantages of the study, patients are assigned to the two study groups by stratified block randomization (main strata: tooth-supported / (tooth-)implant-supported). After placement of the restorations, follow-up examinations are performed after 1 week (baseline) and after half a year, one year, two years and three years. In addition to the main target criterion (veneering defects), further complications (related to FPDs or supporting tissues / structures) and parameters of oral health are recorded. Depending on the distribution and structure of the data, parametric and non-parametric statistics are used. Group differences with respect to the main target criterion ceramic defects are to be investigated by log-rank and chi-square tests. The significance level is set at α < 0.05. Since this is an explorative study, all p-values are descriptive.
- Conditions
- Partial Edentulism
- Being tested
- Monolithic / facially veneered zirconia fixed partial denture, Completely veneered CoCr fixed partial denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolithic / facially veneered zirconia fixed partial dentureDevice
Participant receives one monolithic / facially veneered zirconia fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.
Completely veneered CoCr fixed partial dentureDevice
Participant receives one completely veneered CoCr fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.
| Study group | Role | What they receive |
|---|---|---|
| Monolithic / facially veneered zirconia | Experimental | Participants receive one monolithic / facially veneered zirconia fixed partial denture. Receives: Device: Monolithic / facially veneered zirconia fixed partial denture |
| Completely veneered CoCr | Other | Control group. Participants receive one completely veneered metal ceramic fixed partial denture. Receives: Device: Completely veneered CoCr fixed partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-dependent ceramic defect rate
The time to the occurrence of a ceramic defect is used as the main target criterion. Ceramic defects are identified in a structured clinical examination after cleaning and drying of the restoration surface and with the aid of magnifying glasses.
Measured: 3 years
Secondary outcomes (11)
Restoration survival
Time-dependent survival rate
Measured: 3 years
Abutment-tooth survival
Time-dependent survival rate of abutment teeth
Measured: 3 years
Implant survival
Time-dependent survival rate of implants
Measured: 3 years
Restoration success
Time-dependent complication-free survival rate of restorations
Measured: 3 years
Abutment-tooth success
Time-dependent complication-free survival rate of abutment teeth
Measured: 3 years
Implant success
Time-dependent complication-free survival rate of implants
Measured: 3 years
Risk-factor analysis
Identification of influencing factors (risk factors such as sex, the position of the fixed partial denture in the upper or lower jaw, a tooth or implant-supported design, and the activity of the masticatory muscles) for the occurrence of complications.
Measured: 3 years
Gingival / mucosal, periodontal / periimplant health of the abutment teeth / implants
The gingival / mucosal inflammation is evaluated categorically (0 - 3) on the basis of the gingival index (GI) according to Loe and Silness. Periodontal / periimplant health is assessed by measuring the pocket depth around teeth and implants using a millimeter-scaled periodontal probe and by simultaneously measuring the incidence of bleeding on probing (BOP) and suppuration.
Measured: 3 years
Plaque accumulation
The accumulation of dental / peri-implant plaque is determined categorically (0 - 3) on the basis of the Plaque Index (PI) according to Silness and Loe.
Measured: 3 years
Patients' satisfaction with restoration esthetics
Satisfaction with the esthetics of the restorations is assessed by the patient on a 6-point visual analogue scale.
Measured: 3 years
Wear on the restoration and the natural opposing dentition
Quantification of the clinical wear (vertical height loss and volume loss) that has occurred on the restorations and antagonistic material using 3D superimposed diagnostic models
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start9 Jan 2020
- Primary completionDec 2024 (estimated)
- Study completionJan 2027 (estimated)
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Principal investigator, Dr. Wolfgang Bömicke, University Hospital Heidelberg
- Investigators
- Wolfgang Bömicke, PD Dr. MSc., Principal investigator, Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166695
- Sponsor's protocol ID
- S-682/2019
- Status last verified
- May 2023
- First submitted
- 12 Nov 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Long-span All-ceramic or Metal-ceramic Fixed Partial Dentures on Implants and/or Natural Teeth
- ClinicalTrials.gov ID
- NCT04166695
- Acronym / sponsor ID
- S-682/2019
- Conditions
- Partial Edentulism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Nov 2019 (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.
Tooth-coloured fixed restorations are becoming increasingly popular with patients and dentists. If high-strength all-ceramics such as zirconia are used as the restoration material, a maximum of two adjacent missing teeth can be replaced with the aid of fixed partial dentures (FPDs). For the replacement of a missing anterior or posterior tooth by FPDs, a very good clinical performance similar to that of metal-based, ceramic-veneered restorations can be expected. However, evidence-based statements on the clinical performance of long-span all-ceramic FPDs are difficult because there are only very few studies on this topic, which are also inhomogeneous with regard to the study conditions. Randomized studies to compare monolithic (consisting only of the high-strength framework material) or partially veneered (weaker veneering ceramics in esthetically relevant tooth areas) all-ceramic and classic (completely veneered) metal-ceramic FPDs are lacking. The aim of the current explorative, prospective, randomized, two-arm clinical interventional study is therefore to compare the clinical performance of long-span FPDs (≥ 4 Pontics) made of monolithic / facially veneered zirconium dioxide with a gold standard (completely veneered cobalt chromium (CoCr)-based FPDs). Forty patients will be recruited. Once all inclusion criteria have been established, including the signed informed consent of the patients informed of the content, effort, advantages and disadvantages of the study, patients are assigned to the two study groups by stratified block randomization (main strata: tooth-supported / (tooth-)implant-supported). After placement of the restorations, follow-up examinations are performed after 1 week (baseline) and after half a year, one year, two years and three years. In addition to the main target criterion (veneering defects), further complications (related to FPDs or supporting tissues / structures) and parameters of oral health are recorded. Depending on the distribution and structure of the data, parametric and non-parametric statistics are used. Group differences with respect to the main target criterion ceramic defects are to be investigated by log-rank and chi-square tests. The significance level is set at α < 0.05. Since this is an explorative study, all p-values are descriptive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monolithic / facially veneered zirconia | Experimental | Device: Monolithic / facially veneered zirconia fixed partial dentureParticipants receive one monolithic / facially veneered zirconia fixed partial denture. |
| Completely veneered CoCr | Other | Device: Completely veneered CoCr fixed partial dentureControl group. Participants receive one completely veneered metal ceramic fixed partial denture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is at least 18 years old.
- The patient has unrestricted legal capacity.
- The patient has two posterior teeth (premolars and / or molars) that are to be replaced next to each other.
- The patient is reliable and willing to take part in follow-up examinations regularly and over the entire study period (three years).
- The information about the study has been understood by the patient and the signed declaration of consent has been received.
Key exclusion criteria (15 listed)
- Pregnancy and lactation
- Local and / or systemic acute and / or chronic (also in the past) general medical diseases and conditions that contradict participation in the study and / or expose the patient to a higher risk in the case of participation in the study.
- Severe bruxism diagnosed by a portable electrocardiomyography device (BruxOff) (> 4 bruxism episodes / night)
- Reduced clinical crown height (< 5 mm before tooth preparation)
- Limited periodontal health:
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 |
|---|---|---|
| Monolithic / facially veneered zirconia fixed partial dentureParticipant receives one monolithic / facially veneered zirconia fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth. | Device | Monolithic / facially veneered zirconia |
| Completely veneered CoCr fixed partial dentureParticipant receives one completely veneered CoCr fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth. | Device | Completely veneered CoCr |
Primary outcome
Time-dependent ceramic defect rate
Time frame: 3 years
The time to the occurrence of a ceramic defect is used as the main target criterion. Ceramic defects are identified in a structured clinical examination after cleaning and drying of the restoration surface and with the aid of magnifying glasses.
11 secondary outcomes
Restoration survival
Time frame: 3 years
Abutment-tooth survival
Time frame: 3 years
Implant survival
Time frame: 3 years
Restoration success
Time frame: 3 years
Abutment-tooth success
Time frame: 3 years
Implant success
Time frame: 3 years
Risk-factor analysis
Time frame: 3 years
Gingival / mucosal, periodontal / periimplant health of the abutment teeth / implants
Time frame: 3 years
Plaque accumulation
Time frame: 3 years
Patients' satisfaction with restoration esthetics
Time frame: 3 years
Wear on the restoration and the natural opposing dentition
Time frame: 3 years
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 9 May 2023.
Related trials for Partial Edentulism
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Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
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Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
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Survival of Implant-Supported All-Ceramic Prostheses
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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.
Wolfgang Bömicke, PD Dr. MSc. principal investigator
Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monolithic / facially veneered zirconia fixed partial denture and Completely veneered CoCr fixed partial denture in people with Partial Edentulism, run by University Hospital Heidelberg 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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 9 May 2023. 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?
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?
Contact Wolfgang Bömicke, PD Dr. MSc. (+496221566052, Wolfgang.Boemicke@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-dependent ceramic defect rate (time frame: 3 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 9 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.