Health TrialsbyHealthPanel

Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM

ConditionsJaw, Edentulous, PartiallyMissing Teeth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of Geneva, Switzerland

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB)

    Device

    In group ZR-TiB the implant impressions will be taken using an intra-oral scanner and the respective scanbody. The restorations will be manufactured by means of CAD/CAM procedures using monolithic zirconia. For sufficient aesthetics, the zirconia restorations can be manually veneered with veneering ceramic only at the buccal surface, while the occlusal surface will remain monolithic and will be high-gloss polished. The zirconia restorations will be extra-orally cemented onto titanium base abutments (Straumann® Variobase® for crown, Straumann AG), correctly polished and delivered to the patient, by screw-retention onto the implant.

  • porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)

    Device

    In group PFM-GA implant impression will be taken using a polyvinyl siloxane or polyether impression material in a conventional manner with the use of stock trays and corresponding impression copings. The framework will be manufactured by the lost wax-technique using a gold-abutment (Straumann® Gold abutment for crown, Straumann AG) and a gold-alloy. All metal frameworks will be manually veneered with veneering ceramic, polished and glazed, and delivered to the patient, by screw-retention onto the implant.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: ZR-TiBExperimental treatment 1 intervention
Group B: PFM-GAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Technical complication rate

assessed by USPHS-criteria

Time frame
5 years

Secondary outcomes

1

Survival rate

Time frame
1, 3, 5 years
2

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)

Time frame
1, 3, 5 years
3

Wear rate of restoration and antagonist

assessed by a volumetric analysis software

Time frame
1, 3, 5 years
4

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 \[0-10, where 10 represents the best outcome\]

Time frame
1, 3, 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Geneva, Switzerland

Lead sponsor

ITI Foundation

Collaborator

Source ClinicalTrials.gov
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