Trial document




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  DRKS00007792

Trial Description

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Title

The effect of zinc-D-gluconate on bleeding propensity of the periodontium in patients with chronic parodontitis - a randomised, placebo-controlled, double-blind interventional study

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Trial Acronym

Parozink

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URL of the Trial

http://keine

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Brief Summary in Lay Language

Aim of the studiy is to clarify whether or not zinc as a substitute to nutrition will reduce the clinical signs of inflammation of the gums and the tooth supporting structures. Participants take either the zinc or placebo (one tablet per day) for a time period of 20 days. The main parameter is the so called bleeding on probing. the clinical study will be performed as a randomized, placebo-controlled, double blinded, four centered study with 100 participants.

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Brief Summary in Scientific Language

Periodontitis is a highly prevalent, chronic inflammatory, destructive disease of the tooth supporting structures. Zinc is supposed to have an anti-inflammatory effect in many chronic inflammatory diseases. This is also true for periodontitis. Additionally, lack of zinc is reported as endemic in ageing populations even in developed societies. The study, therefore. has the aim to evaluate the effect of the daily intake of 20 mg zinc-digluconate over 20 days. The primary outcome variable is the reduction in bleeding on probing between baseline and day 21. Secondary outcomes are probing pocket depths and clinical attachment level at six sites per tooth. The analysis follows the intention to treat protocol.

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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

  •   DRKS00007792
  •   2015/02/10
  •   2014/10/28
  •   yes
  •   Approved
  •   A 151/14, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  •   U1111-1167-0943 
  •   2013-001866-40 
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Health Condition or Problem studied

  •   K05.3 -  Chronic periodontitis
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Interventions/Observational Groups

  •   1/d ZinkVerla OTC 20mg 1 tablet oral 1h prior to dinner for 20 days
  •   1/d Placebo 1 tablet oral 1h prior to dinner for 20 days
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   IIb
  •   Yes
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Primary Outcome

reduction in bleeding on probing from baseline to day 21(+2d)
Probing of the periodontal pocket with a blunt probe to provoke bleeding at sixl sites per tooth

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Secondary Outcome

Changes in probing pocket depths and clinical attachment levels between baseline and day 21 (+2d)
Measurement of the probed depths of destruction in mm with a periodontal probe (PCPUNC15) with the references gingival margin and cemento-enamel junction

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2015/02/23
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Indication: chronic parodontis (PSI 3 and 4)
Minimum of gingival bleeding at six different sites
Minimum of 16 own teeth without relevant supernatant crowns or restauration edges
For Females: hormonal contraception

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Exclusion Criteria

Patients requiring acute periodontal or endodontological treatment
Patients with heart-, kidney, liver diseases, as well as know diabetics and tumor patients, especially patients treated with anticoagulants
Patients with injuries in the oral cavity
Known hypersensitivity against one of the applied IMP or their ingredients or medications with similar chemical structure
Patients being treated with antibiotics, anticoagulants or antiphlogistic medication 14 days prior to being enrolled in the study
Participation in another clinical study within the last 3 months prior to the inclusion into this study
Patients, whose health status has influence on performing the study (e.g. increased risk of bacteremia and suppression of the immune system)
Patients taking protein supplements
Pregnancy and breast feeding
Smoking

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Addresses

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    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Akademie für Zahnärtliche Fortbildung
    • Mr.  Dr.  Andreas  Bartols 
    • Lorenzstr. 7
    • 76135  Karlsruhe
    • Germany
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    • Klinik für Zahnerhaltungskunde und Parodontologie Universitätsklinikum Schleswig-Holstein, Christian Albrechts-Universität zu Kiel
    • Mr.  Prof. Dr.  Christof  Dörfer 
    • Arnold-Heller-Str. 3, Haus 26
    • 24103  Kiel
    • Germany
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    • Zahnarztpraxis
    • Mr.  Wolfram  Uhrig 
    • Menzenschwandter Str. 15
    • 79837  St. Blasien
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Zahnerhaltungskunde und Parodontologie
    • Arnold-Heller-Str. 3, Haus 26
    • 24105   Kiel
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.