Trial document




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  DRKS00000080

Trial Description

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Title

Prospective analysis of the incidence of infection after dental intervention in patients with rheumatoid arthritis

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Trial Acronym

ZEBRA

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URL of the Trial

http://rheumatologie.charite.de

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Brief Summary in Lay Language

Rheumatoid arthritis (RA) is a chronic inflammatory disease with destruction of the cartilage and bone structures, with other associated systemic diseases, such as Stroke and myocardial infarction. It was described a relationship between RA and periodontitis. The periodontitis ist a dental surgery as the most common medical intervention result. 40% of the healthy population have a severe degree of periodontitis. These patients is usually below the insertion of dental implants to preserve the quality of life come. International research findings and their own studies show that RA patients have an increased risk for 8fold periodontitis development. There are currently no controlled studies with sufficient case numbers to analyse with the dental intervention outcomes in patients with systemic diseases (e.g RA). Prerequisite for planning such a study include a risk assessment in terms of infection frequency and disturbance of osseointegration of implants for this particular group of patients, often under immunsuppressive therapy, and with other co-morbidities. In addition to a general increased risk of infection in the RA treatment, there is laboratory evidence that the osseointegration by TNFalpha as one of the most significant rheumatological therapy approaches affected. This pilot project will be a prospective data collection at 128 RA patients compared to healthy individuals, the questions on the frequency of infection after dental surgery and the disruption of osseointegration answer to a practical recommendation for the need to develop preventive measures, including integral part of the proposed study approach in perspective after the pilot phase.

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Brief Summary in Scientific Language

This pilot project will be a prospective data collection at 128 RA patients compared to healthy individuals, the questions on the frequency of infection after dental surgery and the disruption of osseointegration answer to a practical recommendation for the need to develop preventive measures, including integral part of the proposed study approach in perspective after the pilot phase.

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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

  •   DRKS00000080
  •   2009/04/02
  •   [---]*
  •   yes
  •   Approved
  •   EA1/237/08, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   rheumatoid arthritis
  •   M05 -  Seropositive rheumatoid arthritis
  •   M06 -  Other rheumatoid arthritis
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Interventions/Observational Groups

  •   RA patients after intervention
  •   normal population after intervention
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Health care system
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

Incidence of infection after dental intervention with a questionnaire

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/06/04
  •   256
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

The RA - patient
- has a RA with the ACR classification criteria of 1987
- is between 18 to 75 years old
- the treating dentist has asked the indication of a dental intervention
- stable anti-rheumatic treatment until four weeks before surgery
- stable NSAID and steroids up to two weeks before surgery
- no intraarticular injection treatment to four weeks before surgery
- sufficient treatment of co-morbidities
- No aspirin-taking up to 7 days before intervention
- No treatment with anticoagulants
- is able to provide patient information to understand and is willing to informed consent to sign

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Exclusion Criteria

- has infectious diseases, which require antibiotic treatment
- has an acute infectious disease
- has a disease, the perioperative antibiotic prophylaxis (e.g heart valve replacement)
- has a psychiatric disorder, which the understanding of the study protocol restricts (incapable)
- Pregnant or breastfeeding women

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Addresses

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    • Charité - Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Ms.  Dr. med.  Jacqueline  Detert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Ms.  Tanja  Braun 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft Lebenswissenschaften 1
    • Mr.  Dr.  Frank  Wissing 
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/11/09
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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.