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

Implant-supported Single Crowns Clinical Trial

— MonoZrO2crown  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02272491
• Other study ID #: 2014-0191
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 1, 2027

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: November 1, 2027
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Implant-supported Single Crowns

Intervention

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)
• PFM crown (Straumann Gold)
Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic

Locations

Country	Name	City	State
Switzerland	Clinic of Reconstructive Dentistry	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	ITI Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

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