Implant Retained CAD-CAM Ceramic Crowns

NCT04773873 | Completed

• 1 other identifier: RCT-Hybrid abutment
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prosthesis Survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occlusal surface wear

  5 years

Other Outcomes (1)

• Bone level

  T1, T3 and T5 years

Study Arms (3)

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

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)

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)

Device: hybrid abutment ceramic polymer infiltrated crown

Interventions

PFM Crowns on gold coping cast-on 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

Also known as: SynOcta gold coping cast-on (Ceramicor)

Arm 1: Porcelain fused to metal (PFM)

hybrid abutment lithium disilicate crown 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

Also known as: hybrid abutment e.max CAD

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

hybrid abutment ceramic polymer infiltrated crown 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

Also known as: hybrid abutment Enamic

Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• evidence of bruxism
• adjacent implants
• implants placed of-axis

Sponsors & Collaborators

• Susanne Scherrer: lead
• ITI Foundation: collaborator

Study Sites (1)

University Clinics of Dental Medicine

Geneva, 1209, Switzerland

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Susanne S Scherrer, Prof, Dr

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Head of Biomaterials

Model Details: 90 RCT crowns will be allocated in three groups of ceramic materials (3 materials) and at two tooth locations (premolar and molar)

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: January 1, 2015
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

CH (1)