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Implant Retained CAD-CAM Ceramic Crowns (RCT-Scherrer)

Primary Purpose

Prosthesis Survival

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
PFM Crowns on gold coping cast-on
hybrid abutment lithium disilicate crown
hybrid abutment ceramic polymer infiltrated crown
Sponsored by
Susanne Scherrer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Survival

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Clinics of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm 1: Porcelain fused to metal (PFM)

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

Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic)

Arm Description

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

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 22, 2021
Last Updated
November 1, 2022
Sponsor
Susanne Scherrer
Collaborators
ITI Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04773873
Brief Title
Implant Retained CAD-CAM Ceramic Crowns
Acronym
RCT-Scherrer
Official Title
Randomized Controlled Clinical Trial (RCT) of Implant-retained Monolithic Chairside-made CAD-CAM Hybrid Abutment Single Crowns
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susanne Scherrer
Collaborators
ITI Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Porcelain fused to metal (PFM)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm 2: Hybrid abutment Lithium disilicate (e.max CAD)
Arm Type
Experimental
Arm Description
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)
Arm Title
Arm 3:Hybrid abutment ceramic polymer infiltrated (Enamic)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
PFM Crowns on gold coping cast-on
Other Intervention Name(s)
SynOcta gold coping cast-on (Ceramicor)
Intervention Description
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
Intervention Name(s)
hybrid abutment lithium disilicate crown
Other Intervention Name(s)
hybrid abutment e.max CAD
Intervention Description
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
Intervention Name(s)
hybrid abutment ceramic polymer infiltrated crown
Other Intervention Name(s)
hybrid abutment Enamic
Intervention Description
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
Primary Outcome Measure Information:
Title
survival
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Occlusal surface wear
Description
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.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Bone level
Description
Bone level changes in mm will be monitored through standardized X Rays from registration bites at various time frames (T1, T3 and T5 years)
Time Frame
T1, T3 and T5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne S Scherrer, Prof, Dr
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinics of Dental Medicine
City
Geneva
ZIP/Postal Code
1209
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Implant Retained CAD-CAM Ceramic Crowns

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