Trial document





This trial has been registered retrospectively.
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  DRKS00003438

Trial Description

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Title

Evaluation of a dental preventive program for 0- to 3 year old Thuringian children, Germany

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Early Childhood Caries (ECC) is most common chronic disease in childhood and affects children`s growth. In cooperation of the Department of Preventive and Paediatric Dentistry (DPPD) and Youth Welfare Office (YWO) of Jena, Thuringia, a preventive program was initiated in 2009.
Purpose of this intersectoral program was the implementation of evidence based preventive and intervention strategies for early ECC onset.
Trained staff of YWO visited all parents of newborns. Parents were advised about oral hygiene including practical tooth brush training, diet, use of fluorides, infectious etiology of ECC and the importance of the first dental visit after tooth eruption. In the first year of live the children were invited by YWO to dental examination and counselling in the DPPD. Children were included in a risk related recall system (quarterly to semiannually). Aim of this study was the investigation of the impact of the program on oral health of the children after 3 and 5 years.
The hypothesis is that with early dental visits and a closed intersectoral cooperation ECC is preventable. For a comprehensive programme evaluation the programme was continued to the age of 5 years.

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Brief Summary in Scientific Language

Background
Early Childhood Caries (ECC) is most common infectious disease in childhood and affects children`s growth. In cooperation of the Department of Preventive and Paediatric Dentistry (DPPD) and Youth Welfare Office (YWO) of Jena, Thuringia, a preventive program was initiated in 2009.
Aim
Purpose of this intersectoral program was the implementation of evidence based preventive and intervention strategies for early ECC onset and the investigation of the impact on oral health of 0-to 3-year old children.
Design
Trained staff of YWO visited all parents of newborns. From 7/2009 to 7/2010 1162 newborns were born and visited by the YWO. Parents were advised about oral hygiene including practical tooth brush training, diet, use of fluorides, infectious etiology of ECC and the importance of the first dental visit after tooth eruption. Parents had the opportunity to take part in the preventive program and received a patient information and consent form. In the first year of live the children were invited by YWO to dental examination and counselling in the DPPD. 512 (44.1%) children were in the intervention group and included in a risk related recall system (quarterly or semiannually). For preventing initial caries progression lesions were treated by fluoride varnish application (Fluoridin N5, VOCO GmbH, Germany). Children for the control group didn`t take part in the preventive program and were invited by YWO to attend a dental examination in the DPPD after 3 and 5 years for a program evaluation.

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Organizational Data

  •   DRKS00003438
  •   2012/02/22
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  •   yes
  •   Approved
  •   2759-02/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   K02 -  Dental caries
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Interventions/Observational Groups

  •   Intervention group received counselling by YWO and take part in the preventive program: first dental visit in first year of life and participation in a risk-related recall system with semiannually or quarterly dental check ups. Initial caries lesions were treated by fluoride varnish application. Evaluation of the program at age 6. Recording of plaque, dmfs/dmft, migration background, socio-economic status
  •   Control group: no participation in preventive program, comparison after 3 years duration
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Scoring by using WHO diagnostic criteria at dmfs/dmft level without radiography. Recording of initial caries lesions, plaque, caries risk, migration background, number of dental appointments, fluoride varnish application, questionaire about socio-economic status, oral hygiene and diet after 3 and 5 years duration of the preventive program

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Secondary Outcome

Statistical analysis using SPSS, logistic regression analysis, ANOVA and chi-square test, p-value of <0.05

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2010/02/27
  •   800
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Months
  •   6   Years
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Additional Inclusion Criteria

Recruitment of the intervention group after birth, counseling by Youth Welfare Office, participation in preventive program, first dental visit in first year of life, risk related recall system with semiannually or quarterly examinations for 6 years

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Exclusion Criteria

No participation in preventive program, nonappearance to dental examinations

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Addresses

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    • Universitätsklinikum Jena Zentrum für Zahn-, Mund- und Kieferheilkunde Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Dr.  Yvonne  Wagner 
    • Bachstr. 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum Jena ZZMK Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Dr.  Yvonne  Wagner 
    • Bachstr. 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum Jena ZZMK Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Dr.  Yvonne  Wagner 
    • Bachstr. 18
    • 07740  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Jena, ZZMK, Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Dr.  Yvonne  Wagner 
    • Bachstr. 18
    • 07740  Jena
    • Germany
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    • BaMed AG
    • Sihleggstrasse 15
    • 8832  Wollerau
    • Switzerland
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    • DGZMK Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde
    • Liesegangstr. 17 a
    • 40211  Düsseldorf
    • Germany
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    • VOCO GmbH
    • P.O.B./Postfach 767
    • 27457  Cuxhaven
    • Germany
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    • Procter & Gamble International Operations S.A.
    • 47, Rte de St. Georges
    • 1213  Petit-Lancy
    • Switzerland
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    • Wrigley GmbH
    • Biberger Str. 18
    • 82008  Unterhaching
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/11/04
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Trial Publications, Results and other Documents

  •   Evaluation of an interdisciplinary preventive programme for early childhood caries: findings of a regional German birth cohort study. DOI: 10.1007/s00784-015-1685-z. CLOI-D-15-00066.1
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* This entry means the parameter is not applicable or has not been set.