Trial document




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  DRKS00000516

Trial Description

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Title

Dental fear in early childhood caries and the caries risk in the permanent dentition - an analytic-epidemiological study

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Trial Acronym

ECC dental fear study - follow-up

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Despite success in dental caries prevention in adolescents, caries prevention in the early primary dentition in some risk groups is less effective. An analytic-epidemiologic study focussed on caries risk factors was designed to evaluate the caries risk in the primary dentition of those patients after 15 yrs. Additionally, risk factors are to be proved to determine its long-term prediction

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Brief Summary in Scientific Language

This is an longitudinal observational study in juvenile patients that were dentally treated under general anaesthesia as a child due to dental anxiety. Primary endpoint is the caries lifetime experience, secondary endpoint is dental anxiety. As a control group, a cohort of juveniles of the same age will serve that were treated ambulantly during the same time period. The evaluation of the endpoint takes place about 15 yrs after the dental treatment

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Organizational Data

  •   DRKS00000516
  •   2011/02/07
  •   [---]*
  •   yes
  •   Approved
  •   39/2010, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1111-4056 
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Health Condition or Problem studied

  •   K02.0 -  Caries limited to enamel
  •   dental anxiety
  •   K02.1 -  Caries of dentine
  •   K02.2 -  Caries of cementum
  •   K02.3 -  Arrested dental caries
  •   K02.8 -  Other dental caries
  •   K02.9 -  Dental caries, unspecified
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Interventions/Observational Groups

  •   test group: children were treated under general anaesthesia due to dental anxiety
  •   control group: ambulant dental treatment of children
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

caries lifetime experience (DMF index) ca. 15 yrs after treatment

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Secondary Outcome

Questionnaire for recording individual dental anxiety according to the HAF scale (Jöhren; 1999)

ca. 15 yrs after treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/09/20
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   27   Years
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Additional Inclusion Criteria

- date of birth 1983-1994
- treated at University Witten/ Herdecke at the
age of 3-5 years.

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Exclusion Criteria

- no dental treatment at the University of
Witten/ Herdecke in the Year 1995
- no given .....

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Witten/Herdecke
    • Mr.  Prof. Dr.  Martin  Butzlaff 
    • Alfred-Herrhausen-Str.50
    • 58448  Witten
    • Germany
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  • start of 1:1-Block address secondary-sponsor
    • [---]*
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universität Witten/ Herdecke Fakultät für Gesundheit i. Gr. Department ZMK Abteilung für Zahnärztliche Propädeutik
    • Mr.  Dr.med.dent; M.Sc.  A. Rainer  Jordan 
    • Alfred-Herrhausen-Str.50
    • 58448  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. Gr. Department ZMK Abteilung für Zahnärztliche Propädeutik
    • Mr.  Dr.med.dent; M.Sc.  A. Rainer  Jordan 
    • Alfred- Herrhausen-Str. 50
    • 58448  Witten
    • Germany
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Sources of Monetary or Material Support

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    • Universität Witten/ Herdecke Fakultät für Gesundheit i. Gr. Department ZMK Abteilung für Zahnärztliche Prothetik
    • Mr.  Dr. med. dent., MSc.  A. Rainer  Jordan 
    • Alfred- Herrhausen- Str.50
    • 58448  Witten
    • 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.