Trial document




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  DRKS00009033

Trial Description

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Title

Evaluation of postoperative swelling following orthognathic surgery

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Trial Acronym

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The operation of malocclusion of the maxilla and the mandibula go along with severe postoperative swelling and neurosensory disturbances in the area of operation. They are necessary, if orthodontic treatmeant alone is not possible. It is very important to control and decrease the swelling (cooling, drugs). The influence of cortisone on postoperative swelling is discussed frequently. Many trials have tried to confirm this assumption. Due to a lack of technical capabilities, their validity is limited. This tiral aims to evaluate the effect of cortisone on postoperative swelling and neurosensory disturbances. Three-dimensional surface scan are a new and promising method to evaluate facial swelling in its complete extension without ionizing radiation.

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Brief Summary in Scientific Language

The aim of the study is to evaluate the course of swelling as well as neurosensory disturbances after orthognathic surgery. Furthermore a possible influence of cortisone is determined. The swelling is evaluated by three-dimensional surface scans and neurosensory disturbances by thermal stimulating. Participants of the trial are patients who receive a maxillary and/or mandibular osteotomy in the department of oral and maxillofacial surgery at the university of freiburg.

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Organizational Data

  •   DRKS00009033
  •   2015/08/11
  •   [---]*
  •   yes
  •   Approved
  •   4/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   postoperative swelling of the face as well as neurosensory disturbances of the inferior alveolar nerve and the infraorbital nerve following orthognathic surgery
  •   K07.1 -  Anomalies of jaw-cranial base relationship
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Interventions/Observational Groups

  •   The study group receives a single injection of cortisone (40mg Fortecortin Inject) 20 minutes before orthognathic-surgery. Swelling is determined by three-dimensional surface scans on the 1. / 2. / 5. / 14. and 90. postoperative day and is compared to the control group. Furthermore, neurosensory disturbances are compared to the control group on the 2. / 5. / 14. and 90. postoperative day.
  •   The control group receives no injection before orthognathic surgery. Swelling is determined by three-dimensional surface scans on the 1. / 2. / 5. / 14. and 90. postoperative day and is compared to the study group. Furthermore, neurosensory disturbances are compared to the study group on the 2. / 5. / 14. and 90. postoperative day.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Primary endpoint of the study is to evaluate the postoperative course of swelling by three-dimensional surface scans on the 1./ 2. / 5. / 14 and 90. postoperative day and to check if there was an influence of cortisone.

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Secondary Outcome

Secondary endpoint is to evaluate the nerval regeneration on the 2. / 5. / 14. and 90. postoperative day by thermal stimulation. A possible influence by cortisone should be reviewed as well.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/08/17
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients undergoing orthognathic surgery in the department of oral and maxillofacial surgery / university of freiburg (LeFort I osteotomy / bilatteral sagittal split osteotomy, bimaxillary osteotomy)

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Exclusion Criteria

chronical infections, coagulopathy, psychical disease,regular medication

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Addresses

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    • Abteilung für Mund-, Kiefer- und Gesichtschirurgie Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.med. Dr. med. dent  Marc  Metzger 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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    • Abteilung für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Freiburg
    • Mr.  Professor Dr.med. Dr. med. dent  Marc  Metzger 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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    • Abteilung für Mund-, Kiefer- und Gesichtschirurgie Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.med. Dr.med. dent.  Marc  Metzger 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Mund-, Kiefer- und Gesichtschirurgie Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. Dr.   Marc  Metzger 
    • Hugstetterstrasse 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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