Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004742

Trial Description

start of 1:1-Block title

Title

Oral health and oral health related quality of life of hospitaized geriatic patients

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

Trial Acronym

Gero-Study

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

The aim of this study is to evaluate and to improve the oral health and oral hygiene as well as oral health related quality of life in hospitalized geriatric patients. Due to general diseases requiring hospitalization, oral hygiene becomes less important and sometimes neglected. This can cause various oral health problems
After oral examination by dentists, patients’ oral hygiene habits are recorded by especially developed questionnaire and the oral health related quality of life with a standardized questionnaire. Patients of the test group receive individual advice and recommendations of suitable oral hygiene measures and hands-on-training provided by dentists. Suitable methods and supplementary devices are trained and patients are motivated to clean mouth, teeth and dentures on a regular basis. Patients of the control group receive individual advice, recommendation and motivation as well, but no hands-on-training of oral hygiene methods.
The hypothesis that hospitalized geriatric patients can improve their oral hygiene after professional advice and hands-on-training of individually adapted measures and methods will be tested.

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

Brief Summary in Scientific Language

Background: Due to the affected general health of hospitalized geriatric patients, oral hygiene is getting less important during hospitalization and occasionally neglected. Deterioration of oral health and oral health related quality of life can occur.
The aim of this study is to evaluate and to improve the oral health status, oral hygiene und denture hygiene of hospitalized geriatric patients.
Material and Methods: 122 patients of the Geriatric Clinic of Jena University Hospital with a MiniMental Status (MMS) after Folstein of at least 24 are included. The first oral examination is taking place short time after admission to the hospital. Dental status, type and quality of prosthesis and periodontal health are recorded as well as oral hygiene (Turesky Index) and denture hygiene (Wefers Denture Hygiene Index). Oral hygiene habits are recorded by especially developed questionnaire and oral health related quality of life is registered with the standardized and validated OHIP-G 14 questionnaire. Oral swab and periodontal plaque sample is taken. Individual oral hygiene measures and methods according to the patient’s requirements and competencies are recommended by dentist. All patients are motivated to clean mouth and teeth on a regular basis. Patients are allocated by random in a test group and a control group. Patients of the test group receive hands-on-training of the individual recommended oral hygiene measures and the use of auxiliary devices by the dentists. Patients of the control group are not getting any practical training. Short time before discharge from the hospital a second examination is undertaken. Oral and denture hygiene is recorded before and after self-cleaning the mouth by the patient and tissue samples are repeated.
Data regarding oral health and oral hygiene at the beginning and at the end of the hospitalisation are compared and analysed, taking into consideration the physical and mental limitations caused by age and poor general health.
The hypothesis that hospitalized geriatric patients can improve their oral hygiene after professional advice and hands-on-training of individually adapted measures and methods will be tested.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004742
  •   2013/02/27
  •   [---]*
  •   yes
  •   Approved
  •   3277-10/11, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1162-5176 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K05 -  Gingivitis and periodontal diseases
  •   K02 -  Dental caries
  •   K03.6 -  Deposits [accretions] on teeth
  •   K06.2 -  Gingival and edentulous alveolar ridge lesions associated with trauma
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Oral Examination and individual recommenations on oral hygiene for hospitaized geraitric patients with MMS (MiniMentalStatus) >=24 + Hands-on-Training of oral hygiene measures
  •   Oral examination and individual recommenatations on oral hygine of hospitalized geriatric patients with MMS (MiniMentalStatus)>=24 (without hands-on-training)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

A-Oral Hygiene, measured by Turesky-Index a) at first examination (short time after admission to the hospital), b) at second examination (short time before discharge) before cleaning by patient, c) at second examination (short time before discharge) after cleaning by patient; B- Denture Hygien measured by Denture Hygiene Index by Wefers a) at first examination (short time after admission to the hospital), b) at second examination (short time before discharge) before cleaning by patient, c) at second examination (short time before discharge) after cleaning by patient.

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

Secondary Outcome

A- Oral hygiene habits, measured by especially developed questionnaire at first examination (short time after admission to the hospital), B-Oral Health related Quality of Life measured by standardized and validated questionnaire OHIP-G-14 at first examination

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/11/08
  •   122
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

MMS (MiniMentalStatus) at least 24

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

Exclusion Criteria

Patient with dementia

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07743  Jena
    • 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 scientific-contact
    • Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde am Zentrum für Zahn-, Mund- und Kieferheilkunde des Universitätsklinikums Jena
    • Ms.  Dr.  Ina Manuela  Schüler 
    • Bachstraße 18
    • 07743  Jena
    • 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
    • Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde am Zentrum für Zahn-, Mund- und Kieferheilkunde des Universitätsklinikums Jena
    • Ms.  Dr.  Ina Manuela  Schüler 
    • Bachstraße 18
    • 07743  Jena
    • 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
    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07743  Jena
    • 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.