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Clinical trials for Orthognathic surgery

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44344   clinical trials with a EudraCT protocol, of which   7373   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    5 result(s) found for: Orthognathic surgery. Displaying page 1 of 1.
    EudraCT Number: 2013-005473-52 Sponsor Protocol Number: 40964 Start Date*: 2014-04-24
    Sponsor Name:Hospital of South West Jutland
    Full Title: Prevention of bleeding and edema in bi-maxillary orthognathic surgery; the effectiveness of tranexamic acid on intraoperative bleeding in orthognathic surgery
    Medical condition: Surgical bleeding during bi-maxillary orthognathic surgery
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10051536 Intraoperative bleeding LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-002197-13 Sponsor Protocol Number: ANE_SEVPRO_2016_01 Start Date*: 2017-02-20
    Sponsor Name:Servicio de Anestesiología y Reanimación
    Full Title: IMPLICATION OF TWO ANESTHETIC TECHNIQUES: SEVOFLURANE VERSUS PROPOFOL TO REDUCE BLOOD LOSS IN ORTHOGNATHIC SURGERY
    Medical condition: Assessment of the bleeding in ortognatic surgery.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-001885-14 Sponsor Protocol Number: HN010/HTF-003 Start Date*: 2005-08-24
    Sponsor Name:Henogen s.a.
    Full Title: A phase II, randomised, double blind, matched pair, controlled study to assess the safety and efficacy of Henogen recombinant soluble human tissue factor (rshTF) on the mandible bone consolidation...
    Medical condition: Orthognathic surgery, cases of Bilateral Sagittal Split Osteotomy (B.S.S.O) of the mandible to achieve facial and occlusal balance. This could create bone gaps or continuity defects. These bone gap...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003646-41 Sponsor Protocol Number: Start Date*: 2011-11-30
    Sponsor Name:Oliver Ploder MD, DDS, PhD
    Full Title: Pilotstudy: randomized, open label, single-center study to investigate the efficacy and safety of NT 201 for the prophylaxis of relapse after advancement of the mandible
    Medical condition: The study will analyse the efficacy of BTX-A to avoid a relapse after advancement of the mandible (BSSO – bilateral sagittal split osteotomy) with more than 5 mm. The tension of the muscle complex ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001397-30 Sponsor Protocol Number: APOS Start Date*: 2021-03-17
    Sponsor Name:Ruprecht-Karls-University Heidelberg, Medical Faculty rep. by University hospital and Commercial Managing Director
    Full Title: APOS study- Antibiotic Prophylaxis for preventing infectious complications in Orthognathic Surgery
    Medical condition: Prophylaxis of postoperative surgical site infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10032531 Other specified bacterial infections in conditions classified elsewhere and of unspecified site LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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