Trial document





This trial has been registered retrospectively.
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  DRKS00014766

Trial Description

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Title

Prospective examination of muscle activity following total allplastic TMJ replacement (TMJ TJR)

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Trial Acronym

EMG TMJ TJR

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URL of the Trial

http:///

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Brief Summary in Lay Language

In patients with end-stage diseases of the temporomandibular joint, congenital malformations with a non-disposition of the temporomandibular joint and tumor-related resections of the temporomandibular joints in recent years, the allplastic reconstruction of the temporomandibular joint by means of temporomandibular joint endoprothesis has gained in importance. The insertion of an endoprothesis leads to both hard (temporomandibular joint) and soft tissue (ligaments, articular disc, lateral pterygoid muscle) destructions. In addition, the coronoid process often needs to be resected for insertion of the prothesis, which leads to loss of the temporals muscle action. The muscle sling of the masseter and the medial pterygoid muscles have to be detached as well, which may affect the possible insertion surface of the m. masseter. It can therefore be assumed that the muscle activity in the range of m. temporalis and m. masseter is limited following this operation. It is to be examined to what extent the unilateral or bilateral integration of an temporomandibular joint endoprothesis affects the muscle activity and the quality of life of the patients.

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Brief Summary in Scientific Language

In patients with end-stage diseases of the temporomandibular joint, congenital malformations and tumor-related resections of the temporomandibular joints in recent years, the allplastic reconstruction of the temporomandibular joint by means of temporomandibular joint total joint replacement (TMJ TJR) has gained in importance. TMJ TJR leads to both hard (temporomandibular joint) and soft tissue (ligaments, articular disc, lateral pterygoid muscle) destructions. In addition, the coronoid process often needs to be resected for insertion of the prothesis, which leads to loss of the temporals muscle action. The muscle sling of the masseter and the medial pterygoid muscles have to be detached as well, which may affect the possible insertion surface and with it the muscle activity of the m. masseter. It can therefore be assumed that the muscle activity in the range of m. temporalis and m. masseter is limited following TMJ TJR. It is to be examined to what extent the unilateral or bilateral integration of a TMJ endoprosthesis affects the muscle activity and the quality of life of the patients.

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Organizational Data

  •   DRKS00014766
  •   2018/05/15
  •   [---]*
  •   yes
  •   Approved
  •   003/17, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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

  •   M00-M25 -  Arthropathies
  •   C00-C14 -  Malignant neoplasms of lip, oral cavity and pharynx
  •   Q87 -  Other specified congenital malformation syndromes affecting multiple systems
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Interventions/Observational Groups

  •   patients before TMJ TJR (Temporomandibular Joint Total Joint Replacement).
    measurements: sEMG, maximum voluntary bite force, pain threshold, quality of life
  •   patients following unilateral TMJ TJR.
    measurements: sEMG, maximum voluntary bite force, pain threshold, quality of life
  •   patients following bilateral TMJ TJR.
    measurements: sEMG, maximum voluntary bite force, pain threshold, quality of life
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Characteristics

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

The muscle activity of the temporal and masseter muscles (s-EMG), measurement of the maximum voluntary bite force, musculoskeletal pain and oral health-related quality of life will be measured before TMJ TJR (Temporomandibular Joint Total Joint Replacement) and at 3, 6 and 12 months post-operatively. Subsequently, the measurements are made annually. The effect of the insertion of TMJ TJR on the masticatory muscles should be checked.

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Secondary Outcome

The study intends to decide on therapeutic measures for patients, treated as well as health policy decisions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/02
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Indication for TMJ TJR (Temporomandibular Joint Total Joint Replacement).
Oral and written consent.

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Exclusion Criteria

lack of consent of the patient,
anatomical contraindications for attachment of the testing equipment.

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Addresses

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Sources of Monetary or Material Support

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    • Rheinische Friedrich-Wilhelms Universität Bonn,ZZMK-Zahnärztliche Prothetik
    • Ms.  PD Dr. med. dent.  Sabine  Linsen 
    • Welschnonnenstr. 17
    • 53111  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.