Trial document




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  DRKS00004570

Trial Description

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Title

Oral hygiene promotion in patients with fixed dental protheses. A randomised controlled study.

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Trial Acronym

OH_P

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Today there are only few studies analysing which technique of tooth brushing is the best. In an earlier study (DRKS 00003488) we found a copmputerbased training of the so called Fonest technique to be superior to the so called Bass technique. In remains however unclear whether this difference is confined to natural teeth or extends to teeth with fixed dental protheses. The hypothesis is thus tested that computerbased training of different brushing techniques improve oral hygiene skills and gingival health at fixed dental prostheses and at natural teeth. Further it is tested that a training of one technique (Fones) leads to better results than a training of the other (Bass).

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Brief Summary in Scientific Language

The study analyses the efficacy of a computerbased training of the Fones vs. the modified Bass techniques in improving oral hygiene skills and gingival health at fixed prostheses and at natural teeth.

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Organizational Data

  •   DRKS00004570
  •   2012/11/29
  •   [---]*
  •   yes
  •   Approved
  •   270/11, 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

  •   K05.1 -  Chronic gingivitis
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Interventions/Observational Groups

  •   Singular training by means of a standardised computerpresentation navigated by the subjects themselves. Contents: Basics of tooth brushing, i.e.. Surfaces that need to be cleaned and by which devices (tooth brush, floss), pressure while brushing and systematic of brushing. The presentation consists of 12 slides containing audio, video, picutrre and text messages. Subjects are asked to brush their teeth from now on as demonstrated here. They further receive a small brochure to be able look up major aspects of their presentations at home.
  •   Singular training by means of a standardised computerpresentation navigated by the subjects themselves. Contents: Basics of tooth brushing (Arm 1) plus modified Bass-technique. The presentation consists of the 12 slides from Arm 1 plus an additional 25 slides explaining the Bass-techique. Subjects are asked to brush their teeth from now on as demonstrated here. They further receive a small brochure to be able look up major aspects of their presentations at home.
  •   Singular training by means of a standardised computerpresentation navigated by the subjects themselves. Contents: Basics of tooth brushing (Arm 1) plus Fones technique. The presentation consists of the 12 slides from Arm 1 plus an additional 25 slides explaining the Fones technique. Subjects are asked to brush their teeth from now on as demonstrated here. They further receive a small brochure to be able look up major aspects of their presentations at home.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Oral hygiene skills after 6 and 12 weeks assessed via marginal plaque index after thorough oral hygiene

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Secondary Outcome

Oral Hygiene Skills after 6 and 12 weeks assessed via the modified Quigley & Hein Index; ginigvitis assessed via papillary bleeding index

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/02/19
  •   99
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

At least 4 teeth with fixed protheses; at least four natural teeth without fixed prostheses; understands german;

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Exclusion Criteria

acute dental treatment needs; habitual use of a powered tooth brush; pacemaker

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Addresses

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    • Institut für Medizinische Psychologie Justus-Liebig-Universität Gießen
    • Ms.  Prof. Dr.  Renate  Deinzer 
    • Friedrichstr. 36
    • 35392  Gießen
    • Germany
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    • Poliklinik für Zahnärztliche Prothetik Justuts‐Liebig‐Universität Gießen
    • Mr.  Prof. Dr.  Bernd  Wöstmann 
    • Schlangenzahl 11
    • 35392  Gießen
    • Germany
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    • Poliklinik für Zahnersatzkunde Philipps‐Universität Marburg
    • Mr.  Prof. Dr.  Reiner  Mengel 
    • Georg Voigt Str. 3
    • 35039  Marburg
    • Germany
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    • Poliklinik für Zahnersatzkunde Philipps-Universität Marburg
    • Mr.  Prof. Dr.  Ulrich  Lotzmann 
    • Georg Voigt Str. 3
    • 35039  Marburg
    • Germany
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    • Institut für Medizinische Psychologie Justus-Liebig-Universität Gießen
    • Ms.  Prof. Dr.  Renate  Deinzer 
    • Friedrichstr. 36
    • 35392  Gießen
    • Germany
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    • Institut für Medizinische Psychologie Justus-Liebig-Universität Gießen
    • Ms.  Prof. Dr.  Renate  Deinzer 
    • Friedrichstr. 36
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische Psychologie Justus-Liebig-Universität Gießen
    • Ms.  Prof. Dr.  Renate  Deinzer 
    • Friedrichstr. 36
    • 35392  Gießen
    • Germany
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    • GABA International
    • CH-4106   Therwil
    • Switzerland
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/04/29
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Trial Publications, Results and other Documents

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