Trial document




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  DRKS00004737

Trial Description

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Title

Oral health and oral health related quality of life of patients with mental disorders hospitalized in Children´s Psychiatric Clinic

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Trial Acronym

[---]*

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URL of the Trial

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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 patients hospitalized in children's psychiatric clinic. Due to mental disorders requiring hospitalization, oral hygiene becomes less important and sometimes neglected. This can cause various oral health problems as dental caries, gingivitis, disturbed tooth eruption and infections.
After oral examination by dentist and assessing the individual Caries risk, patient’s oral hygiene habits are recorded by especially developed questionnaire and the oral health related quality of life with an standardizes questionnaire. Oral hygiene is recorded at the beginning and at the end of the hospitalization period by measuring the distribution of dental plaque. Patients are divided into two groups, test and control. Patients of the test group receive individual advice and recommendations of suitable oral hygiene measures and hands-on-training provided by dentists at first examination visit. Suitable methods and use of supplementary devices are trained and patients are motivated to clean mouth and teeth on a regular basis. Patients of the control group receive those recommendation and training at last examination visit.
The hypothesis that patients hospitalized in children’s psychiatric clinic can improve their oral hygiene after professional advice and hands-on-training of individually adapted measures and methods will be tested.

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Brief Summary in Scientific Language

Background: Due to affected mental health of patients hospitalized in children’s psychiatric clinic, 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 and oral health related quality of life of patients hospitalized in children’s psychiatric clinic.
Material and Methods: 74 patients hospitalized in the children’s psychiatric clinic of the University Hospital Jena between 6 and 18 years of age are included. Patients are divided into two groups, test and control, by random using a randomization tool.
The first oral examination is taking place short time after admission to hospital. Dental status and periodontal health status are recorded as well as oral hygiene status using Turesky-Index. The individual caries risk is assessed with a standard test. Oral hygiene habits are investigated by especially developed questionnaire and oral health related quality of life by standardizes and validated questionnaire CPQ-G11-14. To the patients of the test group are recommended individualized oral hygiene measures and methods according to the requirements and competencies by dentists. Those methods, including the use of auxiliary devices are exercised in hands-on-training provided by dentists. Patients are motivated to clean their mouth and teeth on a regular basis, using the recommended methods. Patients of the control group receive individualized recommendation and practical training at the last examination, taking place short time before discharge from the hospital. Oral hygiene is assessed at the last examination visit before and after cleaning the mouth by the patient itself.
Data regarding oral health, oral hygiene and oral health related quality of life are analyzed taking into consideration the limitations caused by mental disorders.
The hypothesis that patients hospitalized in children’s psychiatric clinic can improve their oral hygiene after professional advice and hands-on-training of individually adapted measures and methods will be tested.

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Organizational Data

  •   DRKS00004737
  •   2013/05/03
  •   [---]*
  •   yes
  •   Approved
  •   3742-04/13, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   U1111-1162-5274 
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Health Condition or Problem studied

  •   K05 -  Gingivitis and periodontal diseases
  •   K02 -  Dental caries
  •   K03.6 -  Deposits [accretions] on teeth
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Interventions/Observational Groups

  •   Test group: oral examination + Caries Risk Test + at first visit: recommendation of individualized oral hygiene measures and hand-on training
  •   Control group: oral examination + Caries Risk Test + at last visit: recommendation of individualized oral hygiene measures and hand-on training
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Characteristics

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

Oral Hygiene Satus, measured by Turesky Index:
1. at first visit, short time after admission to hospital
2. at last visit, short time befor dicharge from hospital; 2.a before tooth brushing
2.b after tooth brushing

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Secondary Outcome

A Oral Hygiene habits measured by especially developed questionnaire at first visit
B Caries Risk measured by standard caries risk test (Cario L Pop) at first visit
C Oral health related quality of life measured by statized and validated questionnaire CPG-G11-14 at first and last visit

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/05/06
  •   74
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

hospitalization at children's psychiatric clinic

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Exclusion Criteria

no informed consent

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • 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
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    • 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
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Sources of Monetary or Material Support

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/20
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* This entry means the parameter is not applicable or has not been set.