Trial document





This trial has been registered retrospectively.
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  DRKS00009490

Trial Description

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Title

Clinical trial to assess the association between oral hygiene and general health in Hessian nursing homes in the framework of the ZPH-Project (Zahnärztliche Pflege Hessen) of the Landeszahnärztekammer Hessen.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study focuses on the relationship between oral hygiene and general condition among residents in nursing homes. Over 80% of nursing home residents need dental treatment and about two-thirds of residents need support in oral care from nursing staff. Nursing staff often overestimate their knowledge regarding oral diseases. On the initiative of the Landeszahnärztekammer Hessen dental training of nursing staff were carried out as part of a pilot study. Thus oral hygiene of the residents could be improved. Due to interactions between oral diseases and the whole organism, such as diabetes, the aim of this study is to show whether a specific training of nursing staff both oral hygiene and general condition can be improved and accordingly also the entire amount of medication can be reduced. The administered medication is documented in the files of residents. It is assumed that the training of nursing staff does not affect the entire medication of nursing home residents. The participants are residents of selected Hessian nursing homes.

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Brief Summary in Scientific Language

The aim of this intervention study is to show whether a dental training of nursing staff, in addition to an improved oral hygiene, results in an improved general condition and thus also in a reduced entire amount of medication. Bidirectional interactions between periodontal disease and diabetes are already proved, relationships with inflammatory rheumatic disease and aspiration pneumonia are discussed. Caregivers in the intervention group were trained every six months for two years by a dentist. The staff of the control group received no training. From the documentation on resident files is recorded, which medication is monthly administered, dose rate and its indication one year before and one respectively two years after the first course of instruction. Therefore it is possible to compare the intervention and control group as well as an intra-individual comparison as mounted sample. It is assumed that the training of nursing staff does not affect the entire medication of nursing home residents.

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Organizational Data

  •   DRKS00009490
  •   2016/03/01
  •   [---]*
  •   yes
  •   Approved
  •   279/13, 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

  •   entire amount of medication
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Interventions/Observational Groups

  •   Nursing staff in selected nursing homes were special trained by a dentist about oral hygiene at home residents in the form of a lecture. The lecture comprised the improvement of oral hygiene, tools for its improved implementation, variations of oral mucosa and systemic results of insufficient oral hygiene. The selection of nursing homes is randomised so that two nursing homes in an urban and two in a rural area were trained, two major (more than 60 residents) and two small nursing homes (less than 60 residents), two private owned and two public owned institutions. The schooling is on four dates every six month. The results are exercised in the everyday care of the residents.The evaluation of the entire medication of residents is carried out before and after schooling.
  •   Nursing staff of the control group received no training. The selection of nursing homes is randomised and includes two nursing homes in urban and two in rural areas, two major (more than 60 residents) and two small (less than 60 residents) nursing homes, two private owned and two public owned institutions. The everyday care is to proceed as normal. The evaluation of the medication is carried out in the same period, which was fixed for the dedicated nursing home of the intervention group.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is the entire amount of medication.
This is descriptive determined from the remedy sheets that are included in the resident files as part of the usual care documentation. There is for each resident tabularly recorded which drug is applied, how often per day, its dose rate, date of prescription and stopping or modification of dose rate. Retrospectively, after all four courses all applied drugs of the residents are monthly measured. The measurement period extends over three years, beginning one year before the first training. Thus it is possible to compare the average dose rate per drug group before and after schooling.

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Secondary Outcome

Frequency of doctor's advices and hospitalization due to which diagnosis. Further parameter are age, sex, height, weight, body mass index, care level, capability to do oral care by themselves, renal insufficiency, permanent catheter.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2015/12/09
  •   1500
  •   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

Participants have to live in the selected nursing homes. They have to live there at least one year before schooling.

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Exclusion Criteria

Residents who lived in the nursing home less than one year before schooling. Residents who died in the prospective period are registered in the death rate.

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Addresses

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    • Landeszahnärztekammer Hessen
    • Rhonestraße 4
    • 60528  Frankfurt
    • Germany
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    • Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnärztliche Prothetik
    • Mr.  Prof. Dr.  Bernd  Wöstmann 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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    • Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Zahnärztliche Prothetik
    • Ms.  Veronika  Blunk 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Hessisches Sozialministerium; Landeszahnärztekammer Hessen; Kassenzahnärztliche Vereinigung
    • 60528   Frankfurt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/12
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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.