Trial document





This trial has been registered retrospectively.
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  DRKS00009286

Trial Description

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Title

Post Operative Bleeding in Dento-Alveolar Surgery

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In today’s ageing societies dentist commonly treat patients with chronic medical conditions requiring regular drug administration. When talking about dental surgical treatment, there is a long and vivid history of discussions, whether or not oral anticoagulation with coumarines needs to be withdrawn or substituted for low-molecular-weight-heparines (LMWH). We report our 8 years experiences of post operative bleeding in daily routine.

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Brief Summary in Scientific Language

Guidelines published by several national organisations (DGMKG, BCSH, AHA/ACC, ACCP) support the unchanged oral anticoagulation therapy in case of dentoalveolar surgery (Schmelzeisen, 2001; Perry et al., 2007; Hirsh et al., 2003; Douketis et al., 2012). In daily routine, bridging therapy with low-molecular-weight-heparines (LMWH) is performed. This study investigated the incidence of postoperative bleeding and associated complications.

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Organizational Data

  •   DRKS00009286
  •   2015/09/07
  •   [---]*
  •   yes
  •   Approved
  •   20/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   T81.0 -  Haemorrhage and haematoma complicating a procedure, not elsewhere classified
  •   D68.3 -  Haemorrhagic disorder due to circulating anticoagulants
  •   T79.2 -  Traumatic secondary and recurrent haemorrhage
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Interventions/Observational Groups

  •   Patients with of post operative bleeding incidents after dentoalveolar surgery (tooth extractions, osteotomies, root resection, implant placement, periodontal treatment, intraoral abscess incisions, biopsies, cystectomies).
    Age, sex, BMI, general health conditions, medication, in house therapy and duration of stay will be recorded.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Post-operative bleeding incident after dental treatment with and without anticoagulant therapy.

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Secondary Outcome

thrombembolic event or newly diagnosed bleeding diathesis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/01/23
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

postoperative bleeding after dentoalveolar surgery, minor intraoral trauma or spontaneous intraoral bleeding
inpatient treatment

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Exclusion Criteria

bleeding after major surgery, e.g. fractures, tumor, orthognatic, major trauma
outpatient treatment

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Freiburg Klinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Klinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg Klinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg Klinik für MKG Chirurgie
    • Mr.  Michael  Ermer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/27
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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.