Trial document




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  DRKS00000097

Trial Description

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Title

Effectiveness of periodontal therapy in HIV-seropositive patients with chronic periodontitis undergoing highly-active antiretroviral therapy

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Trial Acronym

HIV-cP6 study

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URL of the Trial

http://keine

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Brief Summary in Lay Language

It is the aim of this study, to evaluate the clinical effectiveness of a systematic periodontal therapy in HIV-seropositive patients undergoing highly-active antiretriviral therapy after 6 years, to develop treamtment recommendations and a longitudinal supportive periodontal concept.

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Brief Summary in Scientific Language

During the re-evaluation 16 periodontally treated patients with HIV-infection and 16 periodontally treated patients without HIV-infection as active control group are to be followed-up regarding clinical and microbiological parameters.
Clinical periodontal parameters are: attachment level, probing depth, recessions, tooth mobility, an inflammation and oral hygiene index. Futher parameters are smoking habits, informations of past dentists visits, antiretroviral drugs as well as lab parameters like viral load, CD4 counts and teh CD4/8 ratio. A microbiological testing should indicate the extent of bacterial recolonisation. The investigator is blinded to the type of patients (test vs. control group).

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Organizational Data

  •   DRKS00000097
  •   2009/07/28
  •   [---]*
  •   yes
  •   Approved
  •   16/2009, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1111-4056 
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Health Condition or Problem studied

  •   K05.3 -  Chronic periodontitis
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Interventions/Observational Groups

  •   Arm 1: Test group patients with HIV infection

    Scaling / Root planing in 2003, till 2009 supportive periodontal therapy
    post intervention control: clinical parameter of attachment, marginal inflammation, microbial subgingival load
  •   Arm 2: active control group with HIV-seronegative patients

    Scaling / Root planing in 2003, till 2009 supportive periodontal therapy

    post intervention control: clinical parameter of attachment, marginal inflammation, microbial subgingival load
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Single blind
  •   [---]*
  •   Active control
  •   Other
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Target variable: Retention of teeth

Parameter: tooth in situ
Scheduled: 5 yrs postoperative
Methode: clinical oral examination
Instrument: eye, x-ray

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Secondary Outcome

Target parameter I: Microbial load

Parameter: Periodontal pathogens
Schedule: 5 yrs postoperative
Method: DNA-Chip
Instrument: ParoCheck10


Target parameter II: Attachment level

Parameter: Pocket probing depth and recession
Schedule: 5 yrs postoperative
Method: clinical examination
Instrument: WHO periodontal probe

Target parameter III: Marginal inflammation

Parameter: Bleeding on probing of the marginal gingiva
Schedule: 5 yrs postoperative
Method: Bleeding on probing
Instrument: WHO periodontal probe

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/05/15
  •   32
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

-Systematic periodontla therapy in 2003
-HIV-seropositive status (only test group)
-Antiretroviral therapy with immunoreconstitution (only test group)
-Informed consent

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Exclusion Criteria

-Additional systemic diseases associated with periodontal disease (e.g. diabetes mellitus)
-Intake of drugs, that may lead to gingival hyperplasia (e.g. anticonvulsants)
-No informed consent

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Addresses

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    • Universität Witten/Herdecke Geschäftführung Wissenschaftliche Direktion
    • Mr.  Prof. Dr.  Stefan  Zimmer 
    • Alfred-Herrhausen-Str. 50
    • 58455  Witten
    • Germany
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    • Universität Witten/Herdecke Fakultät für Gesundheit i. G. Department für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Propädeutik
    • Mr.  Dr.  A. Rainer  Jordan 
    • Alfred-Herrhausen-Str. 50
    • 58455  Witten
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Universität Witten/Herdecke Fakultät für Gesundheit i. G. Department für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Propädeutik
    • Mr.  Dr.  A. Rainer  Jordan 
    • Alfred-Herrhausen-Str. 50
    • 58455  Witten
    • Germany
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Sources of Monetary or Material Support

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    • Universität Witten/Herdecke Fakultät für Gesundheit i. G. Department für Zahn-, Mund- und Kieferheilkunde Abteilung für Zahnärztliche Propädeutik
    • Mr.  Dr  A. Rainer  Jordan 
    • Alfred-Herrhausen-Str. 50
    • 58455  Witten
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/01
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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.