Trial document




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  DRKS00000240

Trial Description

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Title

Long-term performance and survival rate of press veneered zirconia and monolithic CAD/CAM lithium disilicate crowns: A prospective randomized clinical splitmouth study over 5 years

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of present clinical study is to evaluate the long-term performance of posterior crowns using two different all-ceramic systems (IPS e.max ZirCAD/ ZirPress SC und IPS e.max CAD Ivoclar- Vivadent, Schaan, Lichtenstein). Each patient will receive two crown restorations, with comparable position of the restorations. Recall evaluation is perfomed over a 5 year period after insertion of the restorations. During the observation period after 1 year, 2, 3 and 5 years restorations are investigated and rated according to standardized clinical parameters.

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Brief Summary in Scientific Language

Prosthodonitc restaurations are used to imitate natural teeth in functionand esthetics.The aim of this randomised controlled clinical study is to evaluate the long-term performance of posterior crowns using two different all-ceramic systems (IPS e.max ZirCAD/ ZirPress SC und IPS e.max CAD Ivoclar- Vivadent, Schaan, Lichtenstein). Recall evaluation is perfomed over a 5 year period after insertion of the restorations. A splitmouth design, with comparable position of the restorations is applied in the present clinical study. One of the restorations will be frabricated using IPS e.max ZirCAD/ ZirPress SC ceramics, the other one from IPS e.max CAD. During the observation period (Baseline (2 weeks after insertion), after 1 year, 2, 3 and 5 years all restorations are investigated and rated according to the United States Public Health Service (USPHS) criteria.

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Organizational Data

  •   DRKS00000240
  •   2009/10/27
  •   [---]*
  •   no
  •   Approved
  •   261/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1112-1784 
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Health Condition or Problem studied

  •   fracture of the restoration, secondary caries
  •   K02.9 -  Dental caries, unspecified
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Interventions/Observational Groups

  •   Long-term performance (probe mirror photos) according to USPHS criteria of crown placement of molar teeth in the controlgroup IPS e.max CAD
  •   Long-term performance (probe mirror photos) according to USPHS criteria of crown placement of molar teeth in the controlgroup IPS e.max CAD
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Characteristics

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

primary: Survival time of all-ceramic crowns using two all-ceramic systems (taking ointo account technical, biological failures, necessitating a renewal of the restauration)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2009/11/15
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Two comparable, teeth (molars) in need of a crown restoration, good oral hygiene, healthy periodontal condition, healthy endodontical condition

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Exclusion Criteria

Teeth are not in need of a crown restoration

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Addresses

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    • Ivoclar Vivadent AG
    • Bendererstrasse 2
    • 9494  Schaan / Liechtenstein
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    •   004232353261
    •   004232354261
    •   [---]*
    •   [---]*
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    • Universitätsklinikum Freiburg Klinik für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik
    • Ms.  Dr.  Petra  Güß 
    • Hugstetterstr.55
    • 79104  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Klinik für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Prothetik
    • Ms.  Dr.  Petra  Güß 
    • Hugstetterstr.55
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Ivoclar Vivadent AG
    • Bendererstrasse 2
    • 9494  Schaan / Lichtenstein
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.