Trial document




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  DRKS00010029

Trial Description

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Title

Accuracy of optical vs. conventional impression methods in partially edentulous patients

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Trial Acronym

COIM PEJ

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is the clinical evaluation of the feasibility and accuracy of computerized optical impression making in partially edentulous patients at the Department of Prosthetic Dentistry.
Here, conventional and optical impressions of the upper and lower jaw will be evaluated regarding their compareability using 3D evaluation software. Further, the patients' satisfaction of both techniques will be captured with a specially designed questionnaire (patient reported outcome measures).

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Brief Summary in Scientific Language

The aim of this in vivo study is the clinical evaluation of the feasibility and accuracy in terms of 3D measurements of computerized optical impression making in partially edentulous patients at the Department of Prosthetic Dentistry.
Here, conventional (elastomers) and computerized optical impressions (3M True Definition, 3M ESPE) of the upper and lower jaw will be evaluated regarding their compareability using 3D evaluation software. Further, the patients' satisfaction of both techniques will be captured with a specially designed questionnaire (PROMs; patient reported outcome measures).

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Organizational Data

  •   DRKS00010029
  •   2016/02/17
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  •   yes
  •   Approved
  •   343/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Partially edentulous patients
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Interventions/Observational Groups

  •   Partially edentulous patient in need of an removable partial denture, will receive a conventional impression of the dentated and edentulous spaces using elastomeric materials.
  •   Partially edentulous patient in need of an removable partial denture, will receive a conventional impression of the dentated and edentulous spaces using a computerized optical intraoral scanner.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   No
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Primary Outcome

The feasibility/accuracy of computerized optical impression making will be evaluated using 3D software after the conventional and computerized optical impressions.

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Secondary Outcome

The patient satisfaction of the conventional and computerized impression methods will be evaluated using a specially design questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/03/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Treatment at the Medical Center - University of Freiburg, Center for Dental Medicine, Department of Prosthetic Dentistry
- Partially edentulous patients receiving a prosthetic reconstruction in the upper and/or lower jaw with a varying number of abutment teeth (≥ 2)

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Exclusion Criteria

Infectious diseases, pregnancy, nonage, missing informed consent

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Addresses

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    • Universitätsklinikum Freiburg; Department für Zahn-, Mund- und Kieferheilkunde; Klinik für Zahnärztliche Prothetik
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Department für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik
    • Mr.  Dr. med. dent.  Sebastian  Patzelt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Department für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik
    • Mr.  Dr. med. dent.  Sebastian  Patzelt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Department für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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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.