Trial document





This trial has been registered retrospectively.
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  DRKS00016179

Trial Description

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Title

Oral health and sense of coherence in hematologic-oncologic patients

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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 the assessment of oral health and sense of coherence in hematologic-oncologic in-patients, hospitalized at Jena University Hospital before, during and after intensive chemotherapy. There are included also patients receiving autologous or allogenic blood stemm cell Transplantation. Oral health and sense of coherence of those in-patients are compared to patients without hematologic oncologic diseases.
Possible modifications of oral health Parameters and sense of coherence due to the disease as well as due to the neutropenia caused by citotoxic Treatment are recorded.

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Brief Summary in Scientific Language

The aim of this case controlled prospective study is the assessment of clinical and microbiological oral health Parameters and of the sense of coherence of hematologic oncological patients before, during and after apllication of intensive Chemotherapy. Patients receiving autologious or allogenic blood stem cell transplanations are also included.
Possible modifications of oral health Parameters and sense of coherence due to the disease as well as due to the neutropenia caused by citotoxic Treatment are recorded.
Patients without hematologic oncologic diseases recruited from the dental department serve as control Group.
The results might contribute to establisch enhanced recommendations regarding prevention, early diagnostic and after care for this Patient Group, taking into consideration also oral health Status.

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Organizational Data

  •   DRKS00016179
  •   2018/12/13
  •   [---]*
  •   yes
  •   Approved
  •   5213-07/17, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K03.8 -  Other specified diseases of hard tissues of teeth
  •   K03.6 -  Deposits [accretions] on teeth
  •   K05 -  Gingivitis and periodontal diseases
  •   K12.3 -  Oral mucositis (ulcerative)
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Interventions/Observational Groups

  •   Diagnostic of the periodontal Status (PSI), of the bacterial colonization of the sucus, of the mucosal disorders, of dental caries and assessment of the sense of coherence of patients with hematologic oncologic diseases
  •   Diagnostic of the periodontal Status (PSI), of the bacterial colonization of the sucus, of the mucosal disorders, of dental caries and assessment of the sense of coherence of patients without hematologic oncologic diseases
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Periodontal Status and pathogens at: 1. after diagnosis of the hematologic oncological disorder; 2. in the Phase of neutropenia; 3. in the Phase of Consolidation

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Secondary Outcome

A: Caries
B: dental Plaqie
C: Mucositis
D: Sense of Coherence

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/09/01
  •   72
  •   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

New diagnosis of acute myeloic leukaemia, acute lymphatic leukaemia, myelosysplastic Syndrome, multiple myelom, Lymphom, allogenic or autolious blood stem cell transplantation

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Exclusion Criteria

insulindependent Diabetes, genetic diseases, stroke

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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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    • 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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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.