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Implant Retained CAD-CAM Ceramic Crowns

NCT ID: NCT04773873

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-12-08

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.

Conditions

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Prosthesis Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

90 RCT crowns will be allocated in three groups of ceramic materials (3 materials) and at two tooth locations (premolar and molar)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Porcelain fused to metal (PFM)

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

Group Type ACTIVE_COMPARATOR

PFM Crowns on gold coping cast-on

Intervention Type DEVICE

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

Arm 2: Hybrid abutment Lithium disilicate (e.max CAD)

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)

Group Type EXPERIMENTAL

hybrid abutment lithium disilicate crown

Intervention Type DEVICE

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

Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic)

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)

Group Type EXPERIMENTAL

hybrid abutment ceramic polymer infiltrated crown

Intervention Type DEVICE

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

Interventions

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PFM Crowns on gold coping cast-on

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

Intervention Type DEVICE

hybrid abutment lithium disilicate crown

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

Intervention Type DEVICE

hybrid abutment ceramic polymer infiltrated crown

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

Intervention Type DEVICE

Other Intervention Names

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SynOcta gold coping cast-on (Ceramicor) hybrid abutment e.max CAD hybrid abutment Enamic

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ITI Foundation

INDUSTRY

Sponsor Role collaborator

Susanne Scherrer

OTHER

Sponsor Role lead

Responsible Party

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Susanne Scherrer

Associate Professor, Head of Biomaterials

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Susanne S Scherrer, Prof, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

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University Clinics of Dental Medicine

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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RCT-Hybrid abutment

Identifier Type: -

Identifier Source: org_study_id