Prosthesis SurvivalRCT-ScherrerNCT04773873
Implant Retained CAD-CAM Ceramic Crowns
A study testing PFM Crowns on gold coping cast-on, hybrid abutment lithium disilicate crown and hybrid abutment ceramic polymer infiltrated crown in people with Prosthesis Survival, run by Susanne Scherrer at 1 site in Switzerland.
Trial summary
Newly available ceramic CAD-CAM blocs containing a screw channel for chairside-made crowns to be adhesively cemented to a TiBase abutment and screw-retained to an implant are appealing to the clinician, considering the time efficiency (one appointment) and overall lower costs as no dental laboratory is involved. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- PFM Crowns on gold coping cast-on, hybrid abutment lithium disilicate crown and hybrid abutment ceramic polymer infiltrated crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2015to 8 Dec 2023
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of relevant medical condition
- Need for a single crown on implant in the molar or premolar region with existing adjacent and antagonist teeth
- No active periodontal or pulpal diseases
- Teeth with good restorations
- Straumann regular (premolar) and wide neck (molar) implants, osseo-integrated for a minimum of 2 months and facial keratinized mucosa width of at least 2 mm
- Patient agrees to return for follow-up examinations during 5 years
- Patient agrees to immediately inform the operator in case of problem
Who cannot join
- evidence of bruxism
- 2 adjacent implants
- implants placed of-axis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial (RCT) of Implant-retained Monolithic Chairside-made CAD-CAM Hybrid Abutment Single Crowns
Newly available ceramic CAD-CAM blocs containing a screw channel for chairside-made crowns to be adhesively cemented to a TiBase abutment and screw-retained to an implant are appealing to the clinician, considering the time efficiency (one appointment) and overall lower costs as no dental laboratory is involved. The hypotheses are that the biological (BOP, PD, PCR, implant bone level) and mechanical outcomes (fracture, loss of retention, wear) are equivalent to implant screw-retained Porcelain-Fused-to-Metal (PFM) crowns over a 5 year observation time.This RCT will provide key information as to the cost/benefit, suitability and/or limitations of these chair-side hybrid-abutment crowns in the posterior region.
Read the detailed description
This RCT involves the University of Geneva Dental School and four private practices for which the Geneva Hospital Ethic Committee's approval is required. Patients in need for replacement of single unit posterior teeth will be recruited at the Dental School as well as in the 5 private practices based on specific selection criteria. Patients will be randomly assigned to a restorative group using a computer-generated random number table for allocation.
The CAD-CAM blocs containing a screw channel for implant-retained chairside-made single-unit hybrid-abutment crowns are 1) Lithium-disilicate glass-ceramic (e.max CAD) (G1) and 2) feldspath-ceramic infiltrated by polymer (Enamic) (G2). The CAD-CAM crowns are adhesively cemented to titanium base abutments (Ti-base) and screw-retained to Titanium implants (Straumann Standard Plus) in the premolar (RN) and molar region (WN). Controls are screw-retained PFM crowns (G3). The number of crowns in each group is N=30 (15 molars and 15 premolars) which gives a total of 90 crowns for this study.
Participants are recalled after 1 week-10 days after crown insertion (baseline, T0) and then yearly during 5 years (T1-T5). Digital X-Rays are taken at T0, T1, T3 and T5 with repositionable individual resin bite registrations.
- Conditions
- Prosthesis Survival
- Being tested
- PFM Crowns on gold coping cast-on, hybrid abutment lithium disilicate crown, hybrid abutment ceramic polymer infiltrated crown
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFM Crowns on gold coping cast-onDevice
Also called SynOcta gold coping cast-on (Ceramicor)
Classic impressions are taken by the operators and sent to one and same laboratory who will deliver all the screw-retained PFM restorations. The crowns will be made using a gold coping cast-on synOcta gold abutment (Ceramicor) for wide (WN) or regular (RN) neck
hybrid abutment lithium disilicate crownDevice
Also called hybrid abutment e.max CAD
Intraoral digital impression with respective scanbodies (Sirona) for Cerec OmniCam or Cerec Bluecam over the chosen TiBase. Cerec CAD designing (operator) and CAM milling (Cerec MCXL) of single crowns with perforated blocs (e.max CAD). crystallization/ characterization/ glaze firing for the e.max CAD crown using an oven with specific firing programmes for e.max CAD. Adhesive cementation steps of the ceramic crown onto the TiBase
hybrid abutment ceramic polymer infiltrated crownDevice
Also called hybrid abutment Enamic
Intraoral digital impression with respective scanbodies (Sirona) for Cerec OmniCam or Cerec Bluecam over the chosen TiBase. Cerec CAD designing (operator) and CAM milling (Cerec MCXL) of single crowns with perforated blocs (Enamic). Surface polishing with rubber polishers. Adhesive cementation steps of the ceramic crown onto the TiBase
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Porcelain fused to metal (PFM) | Active comparator | Implant screw-retained PFM crown fabricated by a laboratory using a gold coping cast-on synOcta gold abutment (Ceramicor) for wide (WN) or regular (RN) neck Receives: Device: PFM Crowns on gold coping cast-on |
| Arm 2: Hybrid abutment Lithium disilicate (e.max CAD) | Experimental | Hybrid crown abutment: chairside-made perforated CAD-CAM Lithium disilicate crown (IPS e.max CAD LT A16) adhesively cemented to a TiBase and screw-retained to a Straumann titanium implant (regular and wide neck) Receives: Device: hybrid abutment lithium disilicate crown |
| Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic) | Experimental | Hybrid crown abutment: chairside-made perforated CAD-CAM ceramic-polymer infiltrated crown (Enamic) adhesively cemented to a TiBase and screw-retained to a Straumann titanium implant (regular and wide neck) Receives: Device: hybrid abutment ceramic polymer infiltrated crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
The primary aim is to monitor and compare the survival of the two CAD-CAM hybrid abutment crown materials with that of PFM implant screw-retained crowns in the posterior region over a period of 5 years. The survival data is subdivided into "absolute failures" needing replacement of the restoration and "relative failures" which include complications that could be repaired.
Measured: 5 years
Secondary outcomes (1)
Occlusal surface wear
Surface wear generated at occlusal contacts from antagonist teeth will be monitored using silicone replicas of the crowns poured with epoxy resin and gold-cotaed for scanning electron microscopy. The contact wear surface will be expressed in mm^2. The average roughness in Ra values.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Jan 2015
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies 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
- Model description
- 90 RCT crowns will be allocated in three groups of ceramic materials (3 materials) and at two tooth locations (premolar and molar)
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Scherrer
- Sponsor type
- University, hospital or other
- Collaborators
- ITI Foundation
- Responsible party
- Sponsor-investigator, Susanne Scherrer, University of Geneva, Switzerland
- Investigators
- Susanne S Scherrer, Prof, Dr, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773873
- Sponsor's protocol ID
- RCT-Hybrid abutment
- Acronym
- RCT-Scherrer
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial (RCT) of Implant-retained Monolithic Chairside-made CAD-CAM Hybrid Abutment Single Crowns
- ClinicalTrials.gov ID
- NCT04773873
- Acronym / sponsor ID
- RCT-Scherrer / RCT-Hybrid abutment
- Conditions
- Prosthesis Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Susanne ScherrerUniversity, hospital or other
- Collaborators
- ITI Foundation
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 26 Feb 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.
Newly available ceramic CAD-CAM blocs containing a screw channel for chairside-made crowns to be adhesively cemented to a TiBase abutment and screw-retained to an implant are appealing to the clinician, considering the time efficiency (one appointment) and overall lower costs as no dental laboratory is involved. The hypotheses are that the biological (BOP, PD, PCR, implant bone level) and mechanical outcomes (fracture, loss of retention, wear) are equivalent to implant screw-retained Porcelain-Fused-to-Metal (PFM) crowns over a 5 year observation time.This RCT will provide key information as to the cost/benefit, suitability and/or limitations of these chair-side hybrid-abutment crowns in the posterior region.
Detailed description
This RCT involves the University of Geneva Dental School and four private practices for which the Geneva Hospital Ethic Committee's approval is required. Patients in need for replacement of single unit posterior teeth will be recruited at the Dental School as well as in the 5 private practices based on specific selection criteria. Patients will be randomly assigned to a restorative group using a computer-generated random number table for allocation.
The CAD-CAM blocs containing a screw channel for implant-retained chairside-made single-unit hybrid-abutment crowns are 1) Lithium-disilicate glass-ceramic (e.max CAD) (G1) and 2) feldspath-ceramic infiltrated by polymer (Enamic) (G2). The CAD-CAM crowns are adhesively cemented to titanium base abutments (Ti-base) and screw-retained to Titanium implants (Straumann Standard Plus) in the premolar (RN) and molar region (WN). Controls are screw-retained PFM crowns (G3). The number of crowns in each group is N=30 (15 molars and 15 premolars) which gives a total of 90 crowns for this study.
Participants are recalled after 1 week-10 days after crown insertion (baseline, T0) and then yearly during 5 years (T1-T5). Digital X-Rays are taken at T0, T1, T3 and T5 with repositionable individual resin bite registrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 90 RCT crowns will be allocated in three groups of ceramic materials (3 materials) and at two tooth locations (premolar and molar)
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Porcelain fused to metal (PFM) | Active comparator | Device: PFM Crowns on gold coping cast-onImplant screw-retained PFM crown fabricated by a laboratory using a gold coping cast-on synOcta gold abutment (Ceramicor) for wide (WN) or regular (RN) neck |
| Arm 2: Hybrid abutment Lithium disilicate (e.max CAD) | Experimental | Device: hybrid abutment lithium disilicate crownHybrid crown abutment: chairside-made perforated CAD-CAM Lithium disilicate crown (IPS e.max CAD LT A16) adhesively cemented to a TiBase and screw-retained to a Straumann titanium implant (regular and wide neck) |
| Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic) | Experimental | Device: hybrid abutment ceramic polymer infiltrated crownHybrid crown abutment: chairside-made perforated CAD-CAM ceramic-polymer infiltrated crown (Enamic) adhesively cemented to a TiBase and screw-retained to a Straumann titanium implant (regular and wide neck) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Absence of relevant medical condition
- Need for a single crown on implant in the molar or premolar region with existing adjacent and antagonist teeth
- No active periodontal or pulpal diseases
- Teeth with good restorations
- Straumann regular (premolar) and wide neck (molar) implants, osseo-integrated for a minimum of 2 months and facial keratinized mucosa width of at least 2 mm
Key exclusion criteria (3 listed)
- evidence of bruxism
- 2 adjacent implants
- implants placed of-axis
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 |
|---|---|---|
| PFM Crowns on gold coping cast-onAlso: SynOcta gold coping cast-on (Ceramicor)Classic impressions are taken by the operators and sent to one and same laboratory who will deliver all the screw-retained PFM restorations. The crowns will be made using a gold coping cast-on synOcta gold abutment (Ceramicor) for wide (WN) or regular (RN) neck | Device | Arm 1: Porcelain fused to metal (PFM) |
| hybrid abutment lithium disilicate crownAlso: hybrid abutment e.max CADIntraoral digital impression with respective scanbodies (Sirona) for Cerec OmniCam or Cerec Bluecam over the chosen TiBase. Cerec CAD designing (operator) and CAM milling (Cerec MCXL) of single crowns with perforated blocs (e.max CAD). crystallization/ characterization/ glaze firing for the e.max CAD crown using an oven with specific firing programmes for e.max CAD. Adhesive cementation steps of the ceramic crown onto the TiBase | Device | Arm 2: Hybrid abutment Lithium disilicate (e.max CAD) |
| hybrid abutment ceramic polymer infiltrated crownAlso: hybrid abutment EnamicIntraoral digital impression with respective scanbodies (Sirona) for Cerec OmniCam or Cerec Bluecam over the chosen TiBase. Cerec CAD designing (operator) and CAM milling (Cerec MCXL) of single crowns with perforated blocs (Enamic). Surface polishing with rubber polishers. Adhesive cementation steps of the ceramic crown onto the TiBase | Device | Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic) |
Primary outcome
survival
Time frame: 5 years
The primary aim is to monitor and compare the survival of the two CAD-CAM hybrid abutment crown materials with that of PFM implant screw-retained crowns in the posterior region over a period of 5 years. The survival data is subdivided into "absolute failures" needing replacement of the restoration and "relative failures" which include complications that could be repaired.
1 secondary outcome
Occlusal surface wear
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Susanne S Scherrer, Prof, Dr principal investigator
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 PFM Crowns on gold coping cast-on, hybrid abutment lithium disilicate crown and hybrid abutment ceramic polymer infiltrated crown in people with Prosthesis Survival, run by Susanne Scherrer 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 11 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
survival (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 11 Dec 2023.