Trial document





This trial has been registered retrospectively.
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  DRKS00009395

Trial Description

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Title

Dental injury caused by intraoperative intermaxillary fixation. A prospective comparative study of two techniques.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Comparison of the risk of injury to a tooth root when two different screws are used to secure the bite during fracture management of the lower jaw.

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Brief Summary in Scientific Language

Prospective comparative study between screw-dependent intermaxillary fixation with and without pre-drilling.

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Organizational Data

  •   DRKS00009395
  •   2017/05/09
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  •   no
  •   Approved
  •   EA2/053/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   S02.6 -  Fracture of mandible
  •   S02.5 -  Fracture of tooth
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Interventions/Observational Groups

  •   IMF-screws with pre-drilling
    In this group the MMF screws are applied after a pilot drilling while open reduction and internal fixation of a fracture of the mandible.
  •   IMF-screws without pre-drilling (self-drilling).
    No pre-drilling is required in this group since the screws are self-drilling while open reduction and internal fixation of a fracture of the mandible.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Tooth damage by MMF-screws .
This parameter is raised by a postoperative X-ray image analysis. The tooth damage are graded in 4 degrees (class 0 = no injury of the tooth root, class 1 = less than 50% of the drill hole in the dentin without pulp involvement, class 2 = over 50% of the drill hole in the dentin without pulp involvement, class 3 = pulp injury).

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Secondary Outcome

Damage to the periodontium.
probing depth (in mm), tooth mobility (I-III), percussion test (painful/not painful), thermal pulp sensibility test (reactive/non-reactive), toothache (yes/no).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/01/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

approvability, 4 screws used only during the operation (for spino-mental fixation 2 screws)

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Exclusion Criteria

missing approvability, mentally ill persons, recall of approval, missing approval, postoperatively left screws

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Addresses

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    • Medartis AG
    • Hochbergerstrasse 60E
    • CH-4057  Basel
    • Switzerland
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    • Klinik für Mund-Kiefer-Gesichtschirurgie, Charité - Campus Virchow Klinikum
    • Mr.  Dr.  Stefan  Hartwig 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Klinik für Mund-Kiefer-Gesichtschirurgie, Charité - Campus Virchow Klinikum
    • Mr.  Dr.  Stefan  Hartwig 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Medartis AG
    • Hochbergerstrasse 60E
    • 4057  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.