Trial document





This trial has been registered retrospectively.
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  DRKS00006221

Trial Description

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Title

Cemented vs. screw-retained zirconia based single implant reconstructions: a prospective randomized controlled clinical trial

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Trial Acronym

Atlantis

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Implant-borne reconstructions can either be screw-retained or cemented on implant abutments. Some disadvantages exist using metal abutment with respect to the esthetic outcome compared to zirconia abutments. Metal abutment can cause a grey shadow and a dark discoloration in cases with a thin peri-implant mucosa. To overcome these issues with metal abutments, zirconia abutments were introduced. However, even with white zirconia abutments a slight discoloration of the peri-implant tissue can be observed, predominantly in cases with a thin mucosa.
In this study screw-retained and cemented reconstructions as well as white and pink abutments will be compared.
Originally, a follow-up period of 5 years was planned. Due to an Amendment (06.03.2018) the 40 patients will get two additional follow up visits after 7.5 and 10 years.

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Brief Summary in Scientific Language

The aims of the present study are therefore to test whether or not the use of screw-retained all ceramic implant-borne reconstructions results in clinical, technical, and biologic outcomes similar to those obtained with cemented all ceramic reconstructions and furthermore, to test whether or not the color of the submucosal part of zirconia abutments influences the color of the peri-implant mucosa and therefore the esthetic outcome.

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Organizational Data

  •   DRKS00006221
  •   2014/06/06
  •   [---]*
  •   yes
  •   Approved
  •   KEK-ZH-Nr 2010-0041/5 (PB_2017-00178), Kantonale Ethikkommission Zürich
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Secondary IDs

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Health Condition or Problem studied

  •   K08.1 -  Loss of teeth due to accident, extraction or local periodontal disease
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Interventions/Observational Groups

  •   screw-retained reconstruction, submucosal part in white
  •   screw-retained reconstruction, submucosal part in pink
  •   cemented reconstruction, submucosal part in white
  •   cemented reconstruction, submucosal part in pink
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Marginal bone levels at 1 year of loading (radiological)

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Secondary Outcome

esthetic and biologic parameters at 1, 3, 5, 7 and 10 years (clinical measurements)

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/08/06
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   80   Years
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Additional Inclusion Criteria

Astra-single tooth implant, front teeth and premolars, upper jaw and lower jaw

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Exclusion Criteria

General contraindications against an implant treatment

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Addresses

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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  PD Dr. med. dent.  Daniel  Thoma 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  PD Dr. med. dent.  Daniel  Thoma 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  PD Dr. med. dent.  Daniel  Thoma 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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Sources of Monetary or Material Support

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    • Astra Tech AB
    • P.O. Box 14
    • 43121  Mölndal
    • Sweden
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    •   [---]*
    •   [---]*
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    • Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
    • Mr.  PD Dr. med. dent.  Daniel  Thoma 
    • Plattenstrasse 11
    • 8032  Zürich
    • Switzerland
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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