Jaw, Edentulous, Partially Clinical Trial
— CantileverOfficial title:
Randomized Controlled Clinical Trial of Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia on Titanium Base Abutments or Porcelain-fused to Metal on Gold Abutments
The aim of is to compare the survival rate and technical outcomes of cantilever implant-supported fixed denture prosthetics (cFDPs) made either out of monolithic zirconia bonded to a titanium base in a digital workflow, or porcelain fused-to metal using a gold abutment in a conventional workflow. In addition, biological outcomes, wear patterns, PROMs and time efficiency will be recorded. The null hypothesis is: the reconstruction type does not influence the survival rate and technical outcomes of 2-unit implant-supported cFDP.
Status | Recruiting |
Enrollment | 38 |
Est. completion date | July 2027 |
Est. primary completion date | July 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - Minimal age of 22 years old. - No general medical condition which represents a contraindication to implant treatment - Good oral hygiene (PII = 20%), and healthy periodontal tissues (BOP= 20%) - Two adjacent-teeth gap in posterior maxilla or mandible arch (first premolar, second premolar, first molar, second molar) with an osseointegrated regular or wide-diameter bone-level implant in a prosthetically correct position to allow occlusal screw-retention. Free-end edentulous gaps can also be included - Presence of antagonist occlusal units Exclusion Criteria: - Severe bruxism or clenching habits - Patients with inadequate oral hygiene or persistent intraoral infection - Women who are pregnant or breast feeding at the day of inclusion - Smokers exceeding 15 cigarettes / day, or equivalent; patients chewing tobacco - Unable or unwilling to cooperate for the trial period - Estimated cantilever crown mesial-distal length > 10 mm - Estimated implant crown height (from implant platform to occlusal contact points) > 15 mm |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
University of Geneva, Switzerland | ITI Foundation |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical complication rate | assessed by USPHS-criteria | 5 years | |
Secondary | Survival rate | 1, 3, 5 years | ||
Secondary | Biological parameters | assessed by clinical examination by measuring with a periodontal probe: bleeding on probing (yes/no per site), pocket probing depth (mm), width of keratinized mucosa (mm), assessed by evaluation of standardized x-rays: marginal bone level changes (mm) | 1, 3, 5 years | |
Secondary | Wear rate of restoration and antagonist | assessed by a volumetric analysis software | 1, 3, 5 years | |
Secondary | Patient Reported Outcomes Measures (PROMs) | assessed through questionnaires: Oral Health Impact Profile (OHIP-14) to evaluate oral health-related quality of life [0-4 for each of the 14 questions, where 4 represents the worst outcome]; Visual Analogue Scales (VAS) to evaluate patient experience with the impression procedure [0-10, where 10 represents the best outcome] | 1, 3, 5 years | |
Secondary | Cost-efficiency | assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue) | single-point measure at baseline | |
Secondary | Accuracy of fabrication | measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow) | single-point measure at baseline | |
Secondary | Operator Reported Outcomes Measures | assessed through Visual Analogue Scales (VAS) to evaluate operator experience with the impression procedure and with the adjustment of the restoration [0-10, where 10 represents the best outcome] | single-point measure at baseline |
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