Actively Recruiting
Clinical Performance of Long-span Fixed Partial Dentures
Led by University Hospital Heidelberg · Updated on 2023-05-09
40
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
Sponsors
U
University Hospital Heidelberg
Lead Sponsor
I
Ivoclar Vivadent AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Performance of Long-span Fixed Partial Dentures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 patient has understood the study information and signed the informed consent form.
You will not qualify if you...
- Pregnancy and lactation.
- Local and/or systemic acute and/or chronic medical diseases or conditions that contraindicate participation or increase risk.
- Severe bruxism diagnosed by a portable electrocardiomyography device (more than 4 bruxism episodes per night).
- Reduced clinical crown height less than 5 mm before tooth preparation.
- Limited periodontal health including probing depths greater than or equal to 4 mm with bleeding on probing, furcation involvement greater than Grade I, or abutment tooth mobility greater than Grade I.
- 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.
- Poor oral hygiene.
- Lack of compliance.
- Planned change of residence.
- Rejection of randomisation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Prosthodontics, University Hospital Heidelberg, University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
Research Team
W
Wolfgang Bömicke, PD Dr. MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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