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NCT Number: NCT02272491

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic of Reconstructive Dentistry

Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZrO2 (Straumann CARES)

Device
  • 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)

Device

Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic

Primary outcomes

  1. Technical complication rate

    Time frame: 5 years

    assessed by USPHS-criteria

Secondary outcomes

  1. Survival rate

    Time frame: 6-month, 1, 3, 5, 7, 10 years

  2. Biological complication rate

    Time frame: 6-month, 1, 3, 5, 7, 10 years

    assessed by bleeding on probing, pocket probing depth, marginal bone level

  3. Wear rate of the antagonist

    Time frame: 6-month, 1, 3, 5, 7, 10 years

    assessed by a volumetric analysis software

  4. Technical complication rate

    Time frame: 6-month, 1, 3 , 7, 10 years

    assessed by USPHS-criteria

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • ITI Foundation

Registry information

Official study title

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

Acronym: MonoZrO2crown

Important dates

Study start
2014
Primary completion
2022
Study completion
2027
First posted
Oct 23, 2014
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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