Trial document





This trial has been registered retrospectively.
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  DRKS00003366

Trial Description

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Title

The impact of virulence factor expression in oral biofilms for the immune response

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Trial Acronym

OralMicro

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to demonstrate how the relationship between the composition of oral plaque and the release of bacterial products affects local and systemic inflammatory reactions. For this purpose young healthy volunteers will be advised not to brush their teeth for 21 days and the local and systemic inflammation will be measured as well as the oral plaque will be sampled and analyzed.

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Brief Summary in Scientific Language

The study was aimed to test the hypothesis that the composition and expression of virulence factors in oral biofilms directly effects the local and systemic immune response. 37 young healthy volunteers will be ask to terminate their oral hygiene for a period of 21 days followed by professional oral hygiene. The local and systemic inflammatory response will be characterized by the appropriate markers. Blood will be sampled and the concentrations of hsCRP, IL-6 and MCP-1 will be measured as well as monocyte activity. entrationen von hsCRp, IL-6 und MCP-1 gemessen.
In addition, naturally formed biofilms will be collected at different time points and its microbioms and capacity to induce inflammatory reactions in epithelial cells will be measured.

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Organizational Data

  •   DRKS00003366
  •   2011/11/30
  •   [---]*
  •   yes
  •   Approved
  •   5085, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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

  •   K05.0 -  Acute gingivitis
  •   Young healthy volunteers
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Interventions/Observational Groups

  •   Young healthy volunteers stop their oral hygiene for 21 days. During this period the clinical signs of oral inflammation will be recorded. Parallel blood will be sampled and to detremine inflammatory parameters and monocyte activation. In a second part oral biofilms will be collected from the volunteers for stimulation experiments with epithelial cells. The synthesis of inflammatory mediators will be studies as well as the composition of the biofilms by sequencing techniques and the expression of virulence factors.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

The systemic concentrations of hsCRP will be determined by immunnephelometrie at day 0, 21 and 42 in serum.

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Secondary Outcome

The systemic concentration of IL-6, MCP-1 will be measured in vitro by ELISA, for monocyte activation established assays will be used and the microbial diversity as well as the expression of virulence factors will be determined by sequencing techniques. All measurements will be performed at day 0, 21 and 42.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/03/01
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

No history of any systemic disease

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Exclusion Criteria

Systemic diseases, periodontitis or caries, Medications that interfere with immune response 6 months before the start of the study, pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover
    • Mr.  Prof.Dr.  Jörg  Eberhard 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr.  Jörg  Eberhard 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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  • start of 1:1-Block address public-contact
    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr.  Jörg  Eberhard 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.