Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013517

Trial Description

start of 1:1-Block title

Title

Oral health in people in need in long-term care

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MundPflege

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Developments in oral care and dentistry have enabled more and more older people to keep their own teeth longer. This positive development, however, is offset when the need for long-term care arises and they are less able to look after themselves. Poor dental hygiene leads to a decline in oral health, an increased risk of tooth loss, a deterioration of nutritional status and the development of systemic diseases. Quality of life thus also depends on oral health. For good oral health, proper dental care with personalized oral care guidance is important – in the domestic setting as well as in care homes.
The aim is to maintain and optimize the oral health of those in need of care at home and thereby contribute to the best possible quality of life.
Potential study participants are people who are insured by the participating health insurance funds, whose primary place of residence is in Bremen or Lower Saxony, who are in need of long-term care in accordance with Book XI of the German Social Code, and who do not live in a care home. The study evaluates the utilization of dental services as well the participants’ oral health status after being given individual oral care guidance in the domestic setting.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Recent studies show that people in need of long-term care use dental services much less frequently than non-care dependents. At the same time there is evidence of an increased need for support for daily oral care, also among care dependents in the lower care categories.
The Oral Health Care Project (MundPflege / Oral Care) is testing a new form of care for non-residential care dependents with the aim of enhancing dental care in this group of people. Improving their oral hygiene should lead to an improved oral health-related quality of life – determined among other things by freedom from pain, the ability to adequately chew and swallow food and to speak – and, hence, social participation.
This new form of health care is provided by registered dentists and qualified dental assistants. An essential feature of this scheme is the low-threshold, outreach approach. Long-term care dependents are contacted by their insurance funds and informed about the scheme. Dental appointments are even made for them. After a dental examination and an individual risk analysis in the context of the scheme, patients and their informal caregivers are given individual coaching on oral care by specially trained dental assistants. In this way, care dependents can be visited and looked after in their home environment.
Potential study participants are people who are insured by the participating health insurance funds, whose primary place of residence is in Bremen or Lower Saxony, who are in need of long-term care in accordance with Book XI of the German Social Code, and who do not live in a care home. The study evaluates the utilization of dental services as well the participants’ oral health status after being given individual oral care guidance in the domestic setting.
The evaluation of this new form of health care is based on a two-arm randomized controlled trial (RCT). In addition, a routine analysis of the health fund data is carried out linking the primary patient data of the RCT to the available routine data. In addition, a health economic evaluation and a potential analysis are carried out.
If the evaluation is successful, the goal is to take this new health care form on board as an element of standard care and thus to contribute to the improvement of care standards pursuant to § 22a SGB V of the Federal Joint Committee (G-BA).

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013517
  •   2018/06/11
  •   [---]*
  •   yes
  •   Approved
  •   MundPflege, Ethikkommission der Universität Bremen Bibliothekstr. 1 28359 Bremen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K00-K14 -  Diseases of oral cavity, salivary glands and jaws
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention group: t0: Examination of oral health status and training of the people in need of care to oral care. t1: Application of Oral Health Assessment Tool, Oral Health Impact Profile and Parodontaler Screening Index; data analysis Betriebskrankenkassen.
  •   Control group: t1: Application of Oral Health Assessment Tool, Oral Health Impact Profile and Peridontaler Screening Index; data analysis Betriebskrankenkassen
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Assesment-Tool for an oral health survey (Oral Health Assessment Tool (OHAT)). Starts from November 2018.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Questionnaire: Oral Health Impact Profile (OHIP) and examination to periodontosis by Periodontal Screening Index (PSI). Starts from November 2018.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/04/30
  •   1000
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

long-term care in accordance with book XI of the German Social Code

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

/

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Bremen, SOCIUM Forschungszentrum Ungleichheit und Sozialpolitik, Abteilung Gesundheit, Pflege und Alterssicherung
    • Mr.  Prof. Dr.  Heinz  Rothgang 
    • Postfach 33 04 40
    • 28334  Bremen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Carl von Ossietzky Universität Oldenburg, Department Versorgungsforschung
    • Mr.  Prof. Dr.  Falk  Hoffmann 
    • Ammerländer Heerstraße 140
    • 26111  Oldenburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • BKK Dachverband
    • Mauerstraße 85
    • 10117  Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Kompetenzzentrum für Klinische Studien Bremen (KKSB)
    • Linzer Straße 4
    • 28359  Bremen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universität Bremen, SOCIUM Forschungszentrum Ungleichheit un Sozialpolitik, Abteilung Gesundheit, Pflege und Alterssicherung
    • Ms.  Dr.  Alexandra  Herzberg 
    • Postfach 33 04 40
    • 28334  Bremen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universität Bremen, SOCIUM Forschungszentum Ungleichheit und Sozialpolitik, Abteilung Gesundheit, Pflege und Alterssicherung
    • Ms.  Dr.  Alexandra  Herzberg 
    • Postfach 33 04 40
    • 28334  Bremen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Wegelystraße 8
    • 10623  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.