Unsatisfactory or Defective Restoration of ToothMIZE-FNCT01997827
Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment
A study testing metal-ceramic RBFDP and all-ceramic RBFDP in people with Unsatisfactory or Defective Restoration of Tooth, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment alternatives. Implant therapy is sometimes impossible, however, because of patient-related risk factors or economic issues. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Unsatisfactory or Defective Restoration of Tooth
- What is being tested?
- metal-ceramic RBFDP and all-ceramic RBFDP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Oct 2025
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- missing central or lateral incisor
- regular patient of the department of prosthodontics of the university hospital of heidelberg
- willingness to return for recall examinations on a regular basis
- written informed consent
- abutment teeth are vital or sufficiently endodontically treated
- abutment teeth are periodontally stable
- abutment teeth have only little or no defects of the hardsubstances
Who cannot join
- Pregnancy or breastfeeding
- medically compromised condition not allowing for standard dental treatment
- Patient is not able to give written informed consent
- alcohol or drug abuse
- positive bruxism and parafunctions questionaire
- Bite-Strip > 2
Show all 14Show fewer
- Attrition Score > 3
- deep bite (Angle class II/2)
- abutment tooth height < 4mm
- untreated symptomatic periodontal or endodontic lesions
- abutment tooth mobility > grade I
- known allergies to materials used in this study
- poor dental hygiene
- planned change of residency
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Clinical Performance of Porcelain-fused-to-metal and All-ceramic Resin-bonded Fixed Dental Prostheses in the Anterior Segment - a Randomized Controlled Pilot Study.
Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment alternatives. Implant therapy is sometimes impossible, however, because of patient-related risk factors or economic issues. In such cases therapy with an FDP requires extensive removal of tooth structure to provide enough space for the restoration and to ensure mechanical retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand for minimal invasiveness and have been used clinically successfully. Sometimes, however, patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed while speaking or smiling or account for a colour change of the abutment teeth. Such patients profit from an all-ceramic RBFDP. Today, the clinical performance of metal-based and all-ceramic RBFDPs has not yet been evaluated under randomized controlled conditions. The aim of this pilot study is to calculate the sample size that allows us to accept the hypothesis that metal- and all-ceramic RBFDPs are similar regarding their clinical performance with adequate statistical power.
- Being tested
- metal-ceramic RBFDP, all-ceramic RBFDP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metal-ceramic RBFDPDevice
Rehabilitation of tooth loss with a metal-ceramic RBFDP
all-ceramic RBFDPDevice
Rehabilitation of tooth loss with an all-ceramic RBFDP
| Study group | Role | What they receive |
|---|---|---|
| metal-ceramic RBFDP | Active comparator | Treatment with a metal-ceramic RBFDP Receives: Device: metal-ceramic RBFDP |
| all-ceramic RBFDP | Experimental | Treatment with an all-ceramic RBFDP Receives: Device: all-ceramic RBFDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria
Measured: 12 months
Secondary outcomes (1)
Color change of the abutment teeth
color change measured with a spectrophotometer expressed as ∆E
Measured: before tooth preparation, try-in of the framework, 1 week after cementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Lack of Participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unsatisfactory or Defective Restoration of ToothStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wolfgang Bömicke, University Hospital Heidelberg
- Investigators
- Wolfgang Bömicke, Dr. med. dent., Principal investigator, Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997827
- Sponsor's protocol ID
- S-083/2013a
- Acronym
- MIZE-F
- Status last verified
- Dec 2015
- First submitted
- 18 Nov 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Porcelain-fused-to-metal and All-ceramic Resin-bonded Fixed Dental Prostheses in the Anterior Segment - a Randomized Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT01997827
- Acronym / sponsor ID
- MIZE-F / S-083/2013a
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Nov 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.
Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns and conventional bridges (fixed dental prostheses [FDPs]) are well established treatment alternatives. Implant therapy is sometimes impossible, however, because of patient-related risk factors or economic issues. In such cases therapy with an FDP requires extensive removal of tooth structure to provide enough space for the restoration and to ensure mechanical retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand for minimal invasiveness and have been used clinically successfully. Sometimes, however, patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed while speaking or smiling or account for a colour change of the abutment teeth. Such patients profit from an all-ceramic RBFDP. Today, the clinical performance of metal-based and all-ceramic RBFDPs has not yet been evaluated under randomized controlled conditions. The aim of this pilot study is to calculate the sample size that allows us to accept the hypothesis that metal- and all-ceramic RBFDPs are similar regarding their clinical performance with adequate statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metal-ceramic RBFDP | Active comparator | Device: metal-ceramic RBFDPTreatment with a metal-ceramic RBFDP |
| all-ceramic RBFDP | Experimental | Device: all-ceramic RBFDPTreatment with an all-ceramic RBFDP |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- missing central or lateral incisor
- regular patient of the department of prosthodontics of the university hospital of heidelberg
- willingness to return for recall examinations on a regular basis
- written informed consent
- abutment teeth are vital or sufficiently endodontically treated
Key exclusion criteria (14 listed)
- Pregnancy or breastfeeding
- medically compromised condition not allowing for standard dental treatment
- Patient is not able to give written informed consent
- alcohol or drug abuse
- positive bruxism and parafunctions questionaire
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 |
|---|---|---|
| metal-ceramic RBFDPRehabilitation of tooth loss with a metal-ceramic RBFDP | Device | metal-ceramic RBFDP |
| all-ceramic RBFDPRehabilitation of tooth loss with an all-ceramic RBFDP | Device | all-ceramic RBFDP |
Primary outcome
Success
Time frame: 12 months
restoration/abutment teeth without intervention according to the Fédération dentaire internationale (FDI) World dental federation criteria
1 secondary outcome
Color change of the abutment teeth
Time frame: before tooth preparation, try-in of the framework, 1 week after cementation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Unsatisfactory or Defective Restoration of Tooth
Recruiting
The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.
Unsatisfactory or Defective Restoration of Tooth
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.
Wolfgang Bömicke, Dr. med. dent. 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 metal-ceramic RBFDP and all-ceramic RBFDP in people with Unsatisfactory or Defective Restoration of Tooth, 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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 3 Dec 2015. 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 withdrawn before enrolling participants, so there are no results.
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 (time frame: 12 months). 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 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.