Trial document





This trial has been registered retrospectively.
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  DRKS00000159

Trial Description

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Title

A clinical study about a methylmethacrylatfree and light-curing denture-acrylic (versyo.com) in comparison with a conventional denture-acrylic based on polymethylmethacrylat (PMMA).

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Trial Acronym

Prüfung Prothesenbasiswerkstoff

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URL of the Trial

[---]*

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Brief Summary in Lay Language

On account of a possible incompatibility of denture-acrylics based on polymethylmethacrylat (PMMA) in some patients, a new one-component, light-curing denture-acrylic (Versyo.com) was developed. In comparison to PMMA-based denture-acrylic versyo.com was tested relating to tissue reaction, plaqueadhesion, technical parameters and patient satisfaction. These parameters were reviewed at 3 recalls with intervals of 6 months.

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Brief Summary in Scientific Language

Very little clinical information is available about Versyo.com. Therefore the aim of the study was to evaluate the clinical long-term performance of versyo.com. The study was applied as a split-mouth model. 100 partial dentures were incorporated in patients for replacement of lost teeth. One denture saddle was made of versyo.com, while the other one was made of the denture-acrylic based on PMMA. If there was another mesial saddle, it was made of Versyo.com, but not evaluated. After finishing the therapy 3 recalls in intervals of 6 months were proceeded. One half of the patients got detailed caring demonstrations, the other half received caring brochures. The parameters tissue reaction, plaqueadhesion, technical parameters were evaluated in recalls and rated to a four-stage-scale. Patient satisfaction was ascertained by a questionaire. The denture saddles and the type of caring instructions were randomized.

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Organizational Data

  •   DRKS00000159
  •   2009/08/10
  •   [---]*
  •   yes
  •   Approved
  •   65/01, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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

  •   provision with partial denture for replacement of lost teeth
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Interventions/Observational Groups

  •   one saddle was made of PalaXpress
  •   the other saddle was made of Versyo.Com
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Active control
  •   Prevention
  •   Factorial
  •   [---]*
  •   [---]*
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Primary Outcome

Comparision of the two saddles regarding to plaqueadhesion following 6, 12 and 18 months

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Secondary Outcome

additionally the two saddles were evaluated regarding to oral mucosa, technical condition of the denture`s underpart und uppersite and patients´satisfaction after 6, 12 and 18 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2001/07/30
  •   100
  •   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

-Patients with minimum age 18 years
- Patients, who get a new removeable partial denture
-Patients, who consent to the participation of the study
- Patients, who can keep the appointments for Recalls

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Exclusion Criteria

Patients, who:
-have known allergies of Palaxpress or Versyo.com
-addict drugs and/or alcohol
-have infectious disease
-have malignancy
-get radiotherapy
-are pregnant
-could not consent to the participation of the study
-can't keep the appointments for Recalls conceivable

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Addresses

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    • Heraeus Holding GmbH
    • Postfach 1561
    • 63405  Hanau
    • Germany
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    •   +49 (0) 6181/35-0
    •   +49 (0) 6181/35-35 50
    •   [---]*
    •   [---]*
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    • Med. Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für zahnärztliche Prothetik
    • Mr.  Prof. Dr. med.  Bernd  Wöstmann 
    • Schlangenzahl 14
    • 35385  Giessen
    • Germany
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    • Med. Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für zahnärztliche Prothetik
    • Mr.  Prof. Dr. med.  Bernd  Wöstmann 
    • Schlangenzahl 14
    • 35385  Giessen
    • Germany
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Sources of Monetary or Material Support

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    • Med. Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnärztliche Prothetik
    • Schlangenzahl 14
    • 35385  Giessen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2006/12/21
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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.