Trial document





This trial has been registered retrospectively.
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  DRKS00008848

Trial Description

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Title

Study to compare the effects between the RelaxBogen and its Myo fascial approach with the occlusial splint in TMD and Bruxism therapie

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Trial Acronym

RB2

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URL of the Trial

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Brief Summary in Lay Language

This study aims to achieve and evidence scientifically the benefits of the CE certificated medical device "RelaxBogen" in order to its indication the "Treatment of TMD and Bruxism". The RelaxBogen invented by a dentist and a physiotherapist actually is distributed to ~ 100 patients with impressive results. This study has the goal to show the impact of a myofascial therapie compared to an occlusal approach.

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Brief Summary in Scientific Language

The goal of the therapy with the CE-marked medical product "RelaxBogen" (DIMDI formular #00133244, document-ID: DE/0000046862) is the relaxation of the jaw musculature of patients suffering from Bruxism and/or TMD. The effectiveness of the product should be documented in this study. Based on the myofascial release-technique from the physiotherapy, the RelaxBogen works in a comparable manner. The fascia of the jaw muscles is stretched through light pressure.
This study compares the application of occlusal splints with the therapy of splints and the RelaxBogen.
During the preexamination a pain ananmesis and manual functional analysis is carried out beside the palpation of 42 muscles and six exit points of the trigeminal nerve. Additionally the muscle activity was measured through an EMG. After eight weeks of treatment this variables are compiled again.

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Organizational Data

  •   DRKS00008848
  •   2016/09/16
  •   [---]*
  •   yes
  •   Approved
  •   30/15/2015, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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Health Condition or Problem studied

  •   Temporomandibular Disorder (TMD)/Bruxism
  •   K07.6 -  Temporomandibular joint disorders
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Interventions/Observational Groups

  •   The treatment group is wearing an occlusal splint for at least three month. Through selection at random this group is treated complementary with the RelaxBogen against bruxism and symptoms of temporomandibular disorder (TMD).
  •   The treatment group is wearing an occlusal splint for at least three month.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Medical exit examination after 10 to 12 weeks of treatment with pain anamnesis, SL-NRS-questionnaire according to Stelzenmueller, dental examination, manual functional analysis, review of the application journal and analysis of the EMG-measurement.
Additionally the used RelaxBogen from the intervention group are checked regarding the fitting.

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Secondary Outcome

no secondary outcome is planned

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/07/30
  •   34
  •   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

N=34 with bruxism and TMD symptomes measured with a "Bruxchecker Film" and a TMD investigation by the dentist and with scientific questionaire.
Each patient needs to have, scince minimum of 3 months, an occlusal splint. An other selection criteria is, that the reason for the TMD and Bruxism is restricted to jaw, neck and shoulder pain.
The patients needs to be full aged and need to have no pschological disease.
People which suffue from an alcohol- oder drug disease are eccluded too

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Exclusion Criteria

Exclusion criteria are:
The patient is underaged or not able to give one's consent. Used a RelaxBogen before. Is depressive, a drug abuser or takes medicine that could introduce Bruxism. A trauma in the head area or the cervical spine. Planned dental restoration during the period of the study. The main pain perception analysed in the SLNR-questionaire is not located in the area of the head, shoulders or the neck.

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Addresses

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    • Zahnarztpraxis
    • Mr.  Jochen  Lambers 
    • Schäbkerweg 8
    • 31863  Coppenbrüge
    • Germany
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    • RelaxBogen GmbH
    • Mr.  Christoph  Seidenstücker 
    • Klütstraße 86
    • 31787  Hameln
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Zahnarztpraxis
    • Mr.  Jochen  Lambers 
    • Schäbkerweg 8
    • 31863  Coppenbrügge
    • Germany
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    • Zahnarztpraxis
    • Mr.  Jochen  Lambers 
    • Schäbkerweg 8
    • 31863  Coppenbrügge
    • Germany
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Sources of Monetary or Material Support

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    • RelaxBogen GmbH
    • 31785  Hameln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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