Trial document





This trial has been registered retrospectively.
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  DRKS00003497

Trial Description

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Title

Prospective study on spinal posture (body posture/static) and dental occlusion.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Randomised clinical study on spinal posture and occlusion and the influence of occlusal interventions. Patients with unilateral posterior crossbite in the late deciduous and early mixed dentition were randomized in a control and therapy group. At the first appointment (T1) the following data were recognised: 1. Orthodontic diagnosis. 2. Temporomandibular joint diagnosis by ultrasonic based analysis system (Arcus Digma, KaVo, Germany). 3. Back shape analysis in 3-D light scan projection (Formetric, Dies, Germany). This was followed for the therapy group by orthodontic treatment. For the control group no therpay was performed. The treatment was done after the second appointment (T2) for every control group patient. This is to guarantee that every participant of the study with the same initial diagnosis reveals an adequate treatment. At the second appointment (T2) after 12 months the same examinations as at the first appointment were performed. The therapy effects between therapy and control group between T1 and T2 were differentiated and statistically analysed.

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Brief Summary in Scientific Language

For the scientific work a close cooperation was performed with the coordinating center for clinical studies (KKS) in the university of münster, medical school. A posterior registration has to be applied because at the time of ethical approval in 2002 no german central register was established. For our publication purposes a registration by Biomed Central has to be performed, which is beeing done here.

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Organizational Data

  •   DRKS00003497
  •   2012/01/24
  •   [---]*
  •   yes
  •   Approved
  •   RegIXEhm1, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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

  •   K07.2 -  Anomalies of dental arch relationship
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Interventions/Observational Groups

  •   unilateral posterior crossbite in the late deciduous and early mixed dentition. Here: therapy group receives orthodontic therapy.
  •   unilateral posterior crossbite in the late deciduous and early mixed dentition. Here: control group receives no orthodontic therapy.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
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  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Timeline between start of therapy at the time of the first examination date (T1) and the time of the second appointment (T2) with a time interval of 12 months.

1. Orthodontic diagnosis. 2. Temporomandibular joint diagnosis by ultrasonic based analysis system (Arcus Digma, KaVo, Germany). 3. Back shape analysis in 3-D light scan projection (Formetric, Dies, Germany).

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2003/01/02
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Years
  •   8   Years
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Additional Inclusion Criteria

unilateral posterior crossbite

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Exclusion Criteria

cleft lip and palate, general impairments, syndroms

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Addresses

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    • Poliklinik für Kieferorthopädie, UKM
    • Ms.  Univ.-Prof. Dr. em.  Ulrike 
    • Waldeyerstr. 30,
    • 48149  Münster
    • Germany
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    • Poliklinik für Kieferorthopädie, Universitätsklinikum Münster
    • Mr.  PD Dr. med. dent.  Carsten  Lippold 
    • Waldeyerstr. 30
    • 48149  Münster
    • Germany
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    • Poliklinik für Kieferorthopädie, Universitätsklinikum Münster
    • Mr.  PD Dr. med. dent.  Carsten  Lippold 
    • Waldeyerstr. 30
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik für Kieferorthopädie, UKM
    • Ms.  Univ.-Prof. Dr. em.  Ulrike 
    • Waldeyerstr. 30,
    • 48149  Münster
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2006/01/02
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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.