Trial document




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  DRKS00003266

Trial Description

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Title

Representative electromyographic graded bruxism and its association with temporomandibular disorders

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Trial Acronym

bruxism and TMD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Bruxism and other parafunctions (e.g. grinding) often result in high forces and extreme loading of the stomatognatic system. However, the influence of bruxism on the development of temporomandibular disorders has not been sufficiently investigated. Additionally, bruxer apply high loads on their teeth (respectively their prostheses) which complicates the dental treatment, especially when new fixed or removable dental prostheses are necessary.
Often anamnestic questions are used to assess bruxism. Furthermore tooth wear is analyzed to grade the bruxism. However, both methods are not reliable and do not allow to grade bruxism. Thus, almost no reliable and valide data is available for the common population with respect to bruxism and its association with TMD. The aim aof the present study is to assess the prevalnece of bruxism using a portable EMG-device and to assess the association of bruxism and TMD. 200 subjects should be enrolled (80 with TMD and 120 without TMD [representative sample]). All subjects should be examined clinically and using a portable EMG-device.

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Brief Summary in Scientific Language

Bruxism is describe as a myofunctional disorder which is associated with nocturnal grinding and/or clenching. It is assumed that about 20% of the German population are bruxers. There are various effects of bruxing: excessive tooth wear, pain in the face, pain in the stomatognatic system, ...
TMD (7-day prevalence about 8%), also, might be associated with bruxing. Data about the prevalence of bruxing and its association with TMD are insufficient: no represnetative data based on electromyographic data is available. Most studies used questionnaires and/or did not assess the prevalence in a representative sample. A valide method to assess bruxism is the usage of EMG during sleep.
the aim of the present study is to assess the prevalence of nocturnal bruxism using a portbale EMG and to assess the association with signs and symptoms of TMD. 120 subjects drawn from a representative sample and 80 TMD patients should be enrolled in this study. Beside EMG and a clinical examination, psychosocial aspects sould be documented.
The resulting data would allow to assess the prevalence of bruxism, the association with TMD and would allow to distinguih between "physiologic" nocturnal muscle activity and bruxism.

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Organizational Data

  •   DRKS00003266
  •   2011/09/30
  •   [---]*
  •   yes
  •   Approved
  •   S-322/2011, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   K07.6 -  Temporomandibular joint disorders
  •   F45.8 -  Other somatoform disorders
  •   G47.9 -  Sleep disorder, unspecified
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Interventions/Observational Groups

  •   Representative sample drawn from the inhabitants of Heidelberg, Germany. The nocturnal muscle activity should be recorded during 10 nights using a portable EMG device. Additionally, a clinical examination will be performed.
  •   TMD patients.
    The nocturnal muscle activity should be recorded during 10 nights using a portable EMG device. Additionally, a clinical examination will be performed.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Assessment of the association between bruxism and TMD. The results of the nocturnal muscle activity and the clinical TMD-examination will be correlated.

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Secondary Outcome

Influence of psychosocial aspects.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2012/04/02
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Informed consent
- Aged 18-50 years
- no heart pacemaker
- full legal capacity

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Exclusion Criteria

a) pregnancy or lactating females
b) chronic pain (GCPS 3 and 4)
c) allergic reactions against adhesive plaster
d) electronic implants (pacemaker, defibrillator)
e) facial pain originating from infections, tumors, neurologic diseases etc.
f) Surgery in the facial area and or traumata
g) Insufficient dental treatment associated with pain

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Poliklinik für Zahnärztliche Prothetik
    • Mr.  Prof. Dr.   Marc  Schmitter 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Sekretariat der Poliklinik für Zahnärztliche Prothetik   
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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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.