Monolithic Zirconia Crowns for Single Implants in the Molar Region: a Multicenter Clinical Trial
MonoZrO2crown
1 other identifier
interventional
83
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
ExpectedMay 15, 2023
May 1, 2023
8.2 years
October 10, 2014
May 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Technical complication rate
assessed by USPHS-criteria
5 years
Secondary Outcomes (4)
Survival rate
6-month, 1, 3, 5, 7, 10 years
Biological complication rate
6-month, 1, 3, 5, 7, 10 years
Wear rate of the antagonist
6-month, 1, 3, 5, 7, 10 years
Technical complication rate
6-month, 1, 3 , 7, 10 years
Study Arms (2)
ZrO2
EXPERIMENTAL1. Straumann CARES Variobase Abutment RN 2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)
PFM crown
ACTIVE COMPARATORStraumann Gold Abutment RN Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic
Interventions
1. Straumann CARES Variobase Abutment RN 2. Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)
Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- ITI Foundationcollaborator
Study Sites (1)
Clinic of Reconstructive Dentistry
Zurich, 8032, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Alexis Ioannidis, Dr.
Clinic of Reconstructive Dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2014
First Posted
October 23, 2014
Study Start
October 1, 2014
Primary Completion
November 25, 2022
Study Completion (Estimated)
November 1, 2027
Last Updated
May 15, 2023
Record last verified: 2023-05