Trial document




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  DRKS00005452

Trial Description

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Title

Prospective randomized controlled interventional study of chair-side generated monolithic single implant supra-structures made of lithium disilicate ceramic

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Trial Acronym

Abutment Trial

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URL of the Trial

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Brief Summary in Lay Language

Single implants serve as artificial roots for single crown restorations. A conventional supra-structure consists of a so-called abutment, which serves as an artificial die for the retention of a crown. The standard material for posterior abutments is titanium which is screw retained to the implant. A simple alternative is a monolithic supra-structure made of lithium di-silicate ceramic, which is adhesively luted to a titanium basis. The latter ones only purpose is to serve for the screw retention to the implant. The lithium disilicate ceramic supra-structure is CAD/CAM (by the means of computer aided technology) processed. Instead of a conventional impression 3D optical impressions in the patient´ mouth are done. On the basis on that digital impression the supra-structure is designed virtually on the computer screen and according to the virtual design a monolithic restoration is then milled from a meta-silicate ceramic block. After crystallization a tooth-colored restoration is obtained. The restoration now is adhesively luted to the titanium basis. The aim of this study is to evaluate the long term performance of this material in a clinical trial.
The material is already commercially available on the market and already officially registered for this purpose. Due to the fact that it is monolithic there is no transition and color change in the gingival area, as it is the case of a conventional abutment/crown supra-structure.
In order to compare the conventional and the monolithic supra-structures it is decided by random which kind of restoration is inserted. If a patient receives two implants one implant gets the conventional supra-structure and the other one the monolithic one. If a patient receives one implant it is possible that he/she receives the conventional restoration.
Parameters to be evaluated are:
- Complexity of fabrication
- Patient´s satisfaction
- Longevity of restorations
- Gingival health
First an observation period of three years is planned

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Brief Summary in Scientific Language

Single implants serve as artificial roots for single crown restorations. A conventional supra-structure consists of a so-called abutment, which serves as an artificial die for the retention of a crown. The standard material for posterior abutments is titanium which is screw retained to the implant. A simple alternative is a monolithic supra-structure made of lithium di-silicate ceramic, which is adhesively luted to a titanium basis. The latter ones only purpose is to serve for the screw retention to the implant. The lithium disilicate ceramic supra-structure is CAD/CAM processed. Instead of a conventional impression 3D optical impressions in the patient´ mouth are done. On the basis on that digital impression the supra-structure is designed virtually on the computer screen and according to the virtual design a monolithic restoration is then milled from a meta-silicate ceramic block. After crystallization a tooth-colored restoration is obtained. The restoration now is adhesively luted to the titanium basis. The aim of this study is to evaluate the long term performance of this material in a clinical trial.
The material is already commercially available on the market and already officially registered for this purpose. Due to the fact that it is monolithic there is no transition and color change in the gingival area, as it is the case of a conventional abutment/crown supra-structure.
In order to compare the conventional and the monolithic supra-structures a prospective controlled clinical trial is conducted. If a patient receives two implants one implant gets the conventional supra-structure as a control and the other one the monolithic one. If a patient receives one implant matched pairs are generated and one patient receives the monolithic restoration the other patient the conventional one.
At least 25 patients should be restored with the monolithic restoration.
Parameters to be evaluated are:
- Complexity of fabrication
- Patient´s satisfaction
- Longevity of restorations
- Gingival health
First an observation period of three years is planned

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005452
  •   2013/11/19
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  •   no
  •   Approved
  •   EK 211/13, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

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Health Condition or Problem studied

  •   dental implant supra-structures as rehabilitation of missing single teeth
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Interventions/Observational Groups

  •   monolithic single implant suprastructures made of lithium disilicate
  •   titanium abutment and crown made of lithium disilicate
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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


Survival rate and complication rate over a time period of at least 3 years. Examinations dates: Baseline, annual, clinical examinations: stability of screw retention implant - supra-structure, surface, colour, anatomy, gingiva index, plaque index, PES (Pink Esthetic Score)/WES (White Esthetic Score), periotest measurements, radiologic examinations: x-rays baseline, 12 month, 36 month. measurement of the sulcus fluid rate after one year, photos, intraoral 3D optical impressions

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/11/19
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

signed consent, male and female patients >18 years, ASA Physical Status 1 or 2, indication for single implant(s) in the posterior region, abutment height </= 15 mm, antagonists: fixed prosthesis or natural dentition, pocket depth max. 4 mm, good oral hygiene, no treatment needs at adjacent or antagonist teeth, bone augmentation in implant site is no contra indication

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Exclusion Criteria

restoration height > 15 mm, the minimum thicknesses for the screw canal cannot be obtained, severe diseases like non successfully treated diabetes or hypertension, bisphosphonates, severe smokers, patients with psychological disorders, drug abuse, pregnant or breastfeeding patients, minor patients, patients who are mentally disabled and who are dependent on a legal guardian, patients who are accommodated in a health care institution due to mental disease

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Addresses

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    • Ivoclar Vivadent AG
    • Bendererstrasse 2
    • FL-9494  Schaan
    • Liechtenstein
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    • CAMLOG Foundation
    • Margarethenstrasse 38
    • CH-4053  Basel
    • Switzerland
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    • Lehr- und Forschungsgebiet Computergestützte Zahnmedizin in der Klinik für Zahnärztliche Prothetik und Biomaterialien, Zentrum für Implantologie (Direktor: Univ.-Prof. Dr. S. Wolfart)Uniklinik Aachen
    • Univ.-Prof. Dr. med. dent.  Sven  Reich 
    • Pauwelsstrasse 30
    • 52074  Aachen
    • Germany
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    • Lehr- und Forschungsgebiet Computergestützte Zahnmedizin in der Klinik für Zahnärztliche Prothetik und Biomaterialien, Zentrum für Implantologie (Direktor: Univ.-Prof. Dr. S. Wolfart)Uniklinik Aachen
    • Univ.-Prof. Dr. med. dent.  Sven  Reich 
    • Pauwelsstrasse 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Ivoclar Vivadent AG
    • Bendererstrass 2
    • FL-9494  Schaan
    • Liechtenstein
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    • Camlog Foundation
    • Margarethenstrasse 38
    • CH-4053  Basel
    • Switzerland
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Status

  •   Recruiting ongoing
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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.