Implant Retained CAD-CAM Ceramic Crowns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Clinical Trial (RCT) of Implant-retained Monolithic Chairside-made CAD-CAM Hybrid Abutment Single Crowns

Conditions
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Prosthesis Survival

Intervention / Treatment
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* Device: PFM Crowns on gold coping cast-on
* Device: hybrid abutment lithium disilicate crown
* Device: hybrid abutment ceramic polymer infiltrated crown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: evidence of bruxism 2 adjacent implants implants placed of-axis

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Porcelain fused to metal (PFM)<br>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 | Device: PFM Crowns on gold coping cast-on<br>* 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<br>* Other names: SynOcta gold coping cast-on (Ceramicor);|
| Experimental: Arm 2: Hybrid abutment Lithium disilicate (e.max CAD)<br>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) | Device: hybrid abutment lithium disilicate crown<br>* 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<br>* Other names: hybrid abutment e.max CAD;|
| Experimental: Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic)<br>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) | Device: hybrid abutment ceramic polymer infiltrated crown<br>* 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<br>* Other names: hybrid abutment Enamic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years |