Trial document





This trial has been registered retrospectively.
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  DRKS00003531

Trial Description

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Title

"Differences in DNA-methylation pattern in inflammatory candidate genes in patients with severe generalized periodontitis"

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Periodontal diseases are influenced by a variety of different exogenous and endogenous factors. Among the endogenous mediators the DNA composition (genetic factors) and in recent times modifications in DNA structure (epigenetic factors) of inflammatory candidate genes are discussed. The aim of the present study is to assess the importance of epigenetic modifications (DNA-methylation) for transcriptional and translational expression of cytokines in periodontal disease. These investigations will be carried out in tissue and blood samples of periodontitis patients and periodontal healthy controls. The study should help to improve the understanding of disease related mechanisms and help to develop new diagnosis and therapy strategies.

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Brief Summary in Scientific Language

Periodontitis as a bacterially induced chronic inflammatory disease is triggered by specific host dependent immune response. The expression of the genes involved in inflammatory processes is influenced among others by genetic and epigenetic modifications. Moreover, many risk factors associated with periodontitis, including bacterial occurrence, smoking, or diabetes, are known to induce epigenetic changes. The aim of the present study is to evaluate the impact of epigenetic modification, namely DNA-methylation pattern, on transcriptional and translational regulation of inflammatory genes (cytokines) in periodontitis. In this study epigenetic and functional analyses will carried out in gingival biopsies of patients with inflamed tissue (severe periodontitis) in comparison with healthy gingival biopsies. In further investigations the systemic influence of DNA-methylation will be studied in peripheral blood of the patients. The study should broaden understanding of the inflammatory mechanisms underlying periodontal diseases. Furthermore the study could contribute to the developing of new diagnosis and therapy strategies.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003531
  •   2012/02/14
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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Health Condition or Problem studied

  •   severe forms of periodontitis

    Type II chronic periodontitis (K05.1)
    A localized
    B generalized

    Type III aggressive periodontitis
    A localized
    B generalized
  •   K05.1 -  Chronic gingivitis
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Interventions/Observational Groups

  •   "Patients with severe periodontitits: epigenetic and functional analyses will be carried out in gingival biopsies"
  •   "Periodontitisfree controls: epigenetic and functional analyses will be carried out in gingival biopsies"
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Characteristics

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

"Comparison of DNA methylation pattern in selected cytokine genes in patients with and without periodontitis"

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Secondary Outcome

"Comparison of mRNA- and protein-expression in selected cytokine genes in patients with and without periodontitis"

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/08/12
  •   100
  •   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

unrelated persons
Caucasian origin from Central Germany
> 18 years old
periodontal healthy: - no attachment loss (probing depth ≤ 3.5 mm, no gingival recession due to periodontitis,
severe Period: - attachment loss in at least 30% of the teeth with a minimum pocket depth of 4 mm

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Exclusion Criteria

Pregnancy
Therapy with antibiotics within the last 3 month
Periodontal therapy within the last 6 month
History of diseases associated with periodontitis

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Addresses

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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Zentrum für Zahn-Mund- und Kieferheilkunde Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
    • Ms.  Dr.  Susanne   Schulz 
    • Harz 42a
    • D-06108  Halle
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Zentrum für Zahn-Mund- und Kieferheilkunde Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
    • Ms.  Dr.  Susanne  Schulz 
    • Harz 42a
    • D-06108  Halle
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg Medizinische Fakultät Zentrum für Zahn-Mund- und Kieferheilkunde Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
    • Ms.  Dr.  Susanne  Schulz 
    • Harz 42a
    • D-06108  Halle
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Halle (Saale)
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • 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.