Implant Retained CAD-CAM Ceramic Crowns

Prosthesis Survival Clinical Trial

— RCT-Scherrer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773873
• Other study ID #: RCT-Hybrid abutment
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 8, 2023

Study information

• Verified date: December 2023
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 8, 2023
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthesis Survival

Intervention

Device:
• 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
• 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
• 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

Locations

Country	Name	City	State
Switzerland	University Clinics of Dental Medicine	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Susanne Scherrer	ITI Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone level	Bone level changes in mm will be monitored through standardized X Rays from registration bites at various time frames (T1, T3 and T5 years)	T1, T3 and T5 years
Primary	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	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