Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Multicenter Clinical Trial (MonoZrO2crown)

Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Randomized Controlled Clinical Trial

The aim of the present study is to test whether or not the use of translucent monolithic zirconia crowns bonded to a titanium base abutment perform similar to porcelain-fused-to-metal crowns on single implants in the posterior region.

Study Overview

• Status: Active, not recruiting
• Conditions: Implant-supported Single Crowns
• Intervention / Treatment: Device: ZrO2 (Straumann CARES); Device: PFM crown (Straumann Gold)

Detailed Description

In the majority of studies on implant-supported restorations, a considerable rate of fractures of the veneering ceramic was reported. The clinical data is restricted to full-ceramic implant-supported reconstructions in the anterior region. No clinical data is available on the performance of full-ceramic restorations in the molar region.

The use of translucent monolithic zirconia for implant-supported crowns (without veneering ceramic) may reduce the technical complication rate and allow for sufficient aesthetic results in the molar region. To date, no clinical trial investigating monolithic zirconia crowns for single molar implants is available.

The primary outcome of the study is the technical complication rate. This outcome represents an indicator for the prosthetic success of the implant-supported crown. The main biological secondary outcomes are marginal bone level, histological signs of inflammation, and presence of pathogenic bacteria. Further outcomes are crown survival, wear of the crown and of the antagonist.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Clinic of Reconstructive Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed Consent as documented by signature
• Male and female patients from 18-80 years of age
• Presence of a Straumann Tissue Level implant with a regular platform (4.8 mm diameter platform) in the maxillary or mandibular molar region
• Need for a single implant-supported crown
• Implant position enabling screw-retained crown
• Presence of antagonist

Exclusion Criteria:

• Women who are pregnant at the date of inclusion
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Smoking more than 15 cigarettes a day
• Poor oral hygiene (Plaque Index over 30%)
• Bruxism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZrO2; Straumann CARES Variobase Abutment RN; Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)	Device: ZrO2 (Straumann CARES); Straumann CARES Variobase Abutment RN; Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)
Active Comparator: PFM crown; Straumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic	Device: PFM crown (Straumann Gold); Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical complication rate	assessed by USPHS-criteria	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate		6-month, 1, 3, 5, 7, 10 years
Biological complication rate	assessed by bleeding on probing, pocket probing depth, marginal bone level	6-month, 1, 3, 5, 7, 10 years
Wear rate of the antagonist	assessed by a volumetric analysis software	6-month, 1, 3, 5, 7, 10 years
Technical complication rate	assessed by USPHS-criteria	6-month, 1, 3 , 7, 10 years

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: ITI Foundation
• Investigators: Principal Investigator: Alexis Ioannidis, Dr., Clinic of Reconstructive Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): November 25, 2022
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2014-0191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No