Trial document




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  DRKS00003200

Trial Description

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Title

Alternative procedure to improve the stability of mandibular complete dentures: A pilot study

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Edentulous patients having problems with their dentures almost always complain about the lower denture. If anatomical conditions are poor and implants cannot be inserted, the stability of complete lower dentures entirely depends on muscular support. In such cases the set-up of the teeth determines the denture stability. This implies that the teeth should be set up in a position called the neutral zone where the actions of the accessory masticatory muscles are functionally balanced.
In this pilot study a modified neutral zone technique for long-term modelling of the denture base should be used in order to identify the position where this balance is obtained.

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Brief Summary in Scientific Language

Improvement of the stability of mandibular complete dentures in patients with alveolar atrophy

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Organizational Data

  •   DRKS00003200
  •   2011/10/06
  •   [---]*
  •   yes
  •   Approved
  •   162/11, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  •   U1111-1122-9976 
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Health Condition or Problem studied

  •   K08.2 -  Atrophy of edentulous alveolar ridge
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Interventions/Observational Groups

  •   Monitoring Group: Completely edentulous patients with lower dentures.
    In this pilot study a modified neutral zone technique for long-term modelling of the denture base will be used in order to identify the position where this balance is obtained.
    An acrylic-resin base with posterior occlusal rims will be fabricated and then applied with the thermoplastic denture adhesive Cushion Grip®. After wearing for two days a seal moulding for smoothing the surface will be made and then the model transferred into a denture acrylic. After treatment the patients will be asked to rate the improvement in denture stability and the frequency of pressure sores.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

After treatment the patients were asked to rate the improvement in denture stability on a four grade scale

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Secondary Outcome

Frequency of pressure sores

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/11/01
  •   20
  •   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

Completely edentulous patients with severe problems with their lower dentures were selected for this pilot study. In all patients a previous conventional treatment with a new upper and lower denture had been unsatisfactory and implant treatment was not an option. All patients were still dissatisfied with their lower denture.

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Exclusion Criteria

Patients
• suffer from malignant tumors,
• subject-or radiotherapy have undergone
• unwilling or unable to give their consent to participate in the study.

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Addresses

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    • Universitätsklinikum Gießen und Marburg
    • Rudolf-Buchheim-Str. 8
    • 35392  Giessen
    • Germany
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    • Poliklinik für Zahnärztliche Prothetik Justus-Liebig-Universität Gießen
    • Mr.  Prof. Dr.  Bernd  Wöstmann 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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    • Poliklinik für Zahnärztliche Prothetik Justus-Liebig-Universität Gießen
    • Mr.  Prof. Dr.  Bernd  Wöstmann 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik für Zahnärztliche Prothetik Justus-Liebig-Universität Gießen
    • Mr.  Prof. Dr.  Bernd  Wöstmann 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/05/01
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Trial Publications, Results and other Documents

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