Trial document




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  DRKS00014561

Trial Description

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Title

Impact of professional brushing and dental care among nursing home residents - a controlled interventional study

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Trial Acronym

Iopb

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Main objective of this trial is to verify if additional professional dental cleaning with nursing home residents (in need of additional care) may lead to improvements in nutritional status, oral health and mental ability.
The cleanings are carried out weekly by dental staff.

Furthermore the results are then compared to a nursing home, which is under newly dental care with the framework of german statutory insurance.

In addition it will also be evaluated if the benefits of german public health will lead to an improvement of nutritional status, oral health and mental ability.

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Brief Summary in Scientific Language

Main objective of this trial is to verify if additional professional dental cleaning with nursing home residents (in need of additional care) may lead to improvements in nutritional status, oral health and mental ability.
The cleanings are carried out weekly by dental staff.

Furthermore the results are then compared to a nursing home, which is under newly dental care with the framework of german statutory insurance.

In addition it will also be evaluated if the benefits of german public health will lead to an improvement of nutritional status, oral health and mental ability.

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Organizational Data

  •   DRKS00014561
  •   2018/06/20
  •   [---]*
  •   yes
  •   Approved
  •   18-116, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   K05 -  Gingivitis and periodontal diseases
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Interventions/Observational Groups

  •   Treatment following the rules of german statutory health insurance, instruction of caregivers, hygiene status, general dental treatment
  •   Following the rules of german statutory health insurance (BEMA), in addition to regular weekly professional cleaning, during the whole follow-up (minimum after 6 month)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

data collection at beginning, after 6 month, every 6 month, data collection of 1 year

DMF/T,Toothloss, Rootcaries,
Mini Nutritional Assessment,
Demtec (Dementia-Detektion),
MMSE (Mini-Mental-Status-Test),
Clocktest,
GOHAI (Geriatric/General Oral Health Assessment Index)

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Secondary Outcome

Olfactory sense, Salivation, Oral hygiene, Prothesis status

DMFT Index (Decayed/Missing/Filled Teeth)
CPITN (Community Periodontal Index of Treatment Needs)
OHI (Oral hygiene index)
PBI (Papilla-bleeding)
QHI (Quigely Hein Index)
PI (Periodontoal index)
GI (Gingival index)
Leftovers-Index

data collection at beginning, after 6 month, every 6 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/07/20
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Nursing home residents, in need of additional care, with or without dementia, consenting, at least 4 tooth left

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Exclusion Criteria

life threating disease or prefinal

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Addresses

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    • Universitätsklinikum - Köln (AöR)50924 Köln
    • 50931  Köln
    • Germany
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    • Poliklinik für Zahnerhaltung und Parodontologie
    • Ms.  Dr. Dr.  Greta  Barbe 
    • Kerpener Str. 32
    • 50937  Köln
    • Germany
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    • Poliklinik für Zahnerhaltung und Parodontologie
    • Ms.  Dr. Dr.  Greta  Barbe 
    • Kerpener Str. 32
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum - Köln (AöR)
    • 50924  Köln
    • Germany
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Status

  •   Recruiting ongoing
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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.