Jaw, Edentulous, PartiallyCantileverNCT04713800
Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM
A study testing Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB) and porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA) in people with Jaw, Edentulous, Partially and Missing Teeth, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially, Missing Teeth
- What is being tested?
- Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB) and porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Jul 2021to Jul 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva, 1211
João Pitta, Dr
About this study
Official 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.
- Conditions
- Jaw, Edentulous, Partially, Missing Teeth
- Being tested
- Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB), porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)
- Keywords
- Dental Implants, Cantilever, Titanium base, Dental abutment, Fixed dental prosthesis, Monolithic zirconia, Porcelain fused to metal
- Medical subject headings
- Jaw, Edentulous, Partially, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB)Device
Also called Straumann® Variobase® for crown
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
Also called Straumann® Gold abutment for crown
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.
| Study group | Role | What they receive |
|---|---|---|
| ZR-TiB | Experimental | Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR) Receives: Device: Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB) |
| PFM-GA | Active comparator | Porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM) Receives: Device: porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical complication rate
assessed by USPHS-criteria
Measured: 5 years
Secondary outcomes (7)
Survival rate
Measured: 1, 3, 5 years
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)
Measured: 1, 3, 5 years
Wear rate of restoration and antagonist
assessed by a volumetric analysis software
Measured: 1, 3, 5 years
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]
Measured: 1, 3, 5 years
Cost-efficiency
assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue)
Measured: single-point measure at baseline
Accuracy of fabrication
measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow)
Measured: single-point measure at baseline
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]
Measured: single-point measure at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start28 Jul 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ITI Foundation
- Responsible party
- Principal investigator, João Pitta, University of Geneva, Switzerland
- Investigators
- João Pitta, Dr, Principal investigator, University of Geneva, SwitzerlandIrena Sailer, Prof, Study chair, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713800
- Sponsor's protocol ID
- Cantilver study
- Acronym
- Cantilever
- Status last verified
- Nov 2022
- First submitted
- 12 Jan 2021
- Last updated
- 23 Nov 2022
- 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 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04713800
- Acronym / sponsor ID
- Cantilever / Cantilver study
- Conditions
- Jaw, Edentulous, Partially, Missing Teeth
- Keywords
- Dental Implants, Cantilever, Titanium base, Dental abutment, Fixed dental prosthesis, Monolithic zirconia, Porcelain fused to metal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- ITI Foundation
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Jan 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZR-TiB | Experimental | Device: Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB)Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR) |
| PFM-GA | Active comparator | Device: porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)Porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB)Also: Straumann® Variobase® for crownIn 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. | Device | ZR-TiB |
| porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)Also: Straumann® Gold abutment for crownIn 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. | Device | PFM-GA |
Primary outcome
Technical complication rate
Time frame: 5 years
assessed by USPHS-criteria
7 secondary outcomes
Survival rate
Time frame: 1, 3, 5 years
Biological parameters
Time frame: 1, 3, 5 years
Wear rate of restoration and antagonist
Time frame: 1, 3, 5 years
Patient Reported Outcomes Measures (PROMs)
Time frame: 1, 3, 5 years
Cost-efficiency
Time frame: single-point measure at baseline
Accuracy of fabrication
Time frame: single-point measure at baseline
Operator Reported Outcomes Measures
Time frame: single-point measure at baseline
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 23 Nov 2022.
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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.
João Pitta, Dr principal investigator
University of Geneva, Switzerland
Irena Sailer, Prof study chair
University of Geneva, Switzerland
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 zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB) and porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA) in people with Jaw, Edentulous, Partially and Missing Teeth, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 7 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 23 Nov 2022. 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 Switzerland. 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 João Pitta, Dr (+41223794088, joao.pitta@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical complication rate (time frame: 5 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 23 Nov 2022.