Trial document




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  DRKS00006841

Trial Description

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Title

Maintenance of oral health in preterm children by preventive oral care

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Trial Acronym

Preterm Children Study Long

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In 2011 9% of all births in Germany were preterm, which is one of the highest rates of preterm birth in Europe. Preterm birth can affect multiple internal organs and organ-systems. Regarding oral structures, in preterm children oral health problems such as tooth developmental problems, tooth eruption disorders and jaw abnormalities are often observed. One of the most common complications are defects of the tooth structure in form of enamel hypoplasia in the deciduous and permanent dentition, which are associated with a higher risk of caries. The present study is observing, if oral health of preterm children will enhance by intensive caries-preventive measures in comparison with basic caries-preventive measures. Therfore, patients are split into two groups. One group receives basic caries-prevention program and the other group intensive caries-prevention program. In addition, the relationship between the nutritional status of preterm children and their tooth developmant is analysed. As a result of this study, evidence based recommendations for preventive measures in order to maintain oral health in preterm children are deducted.

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Brief Summary in Scientific Language

The aims of this prospective interventional case-control study with a randomized patient selection are 1. to compare oral health status of preterm children after basic prevention program and after intensified prevention program. 2. to analyse the relationship between nutrition status and tooth development in preterm children. 3. to develop evidence based preventive and therapeutic recommendations for this specific group of patients.

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Organizational Data

  •   DRKS00006841
  •   2015/04/09
  •   [---]*
  •   yes
  •   Approved
  •   4111-06/14, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   U1111-1162-5414 
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Health Condition or Problem studied

  •   K02 -  Dental caries
  •   K00 -  Disorders of tooth development and eruption
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Interventions/Observational Groups

  •   Intervention Group: oral examination, oral hygiene status, professional tooth cleaning.Topical Fluoridation (22.500 ppm Fluoride) quarterly starting after eruption of the first tooth
  •   Kontrol Group: oral examination, oral hygiene status, professional tooth cleaning and topical Fluoridation (22.500 ppm Fluoride) half yearly
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Caries experience measured with the Decayed - Missing - Filled - Teeth Index in the primary and permanent dentition
(dmft/DMFT) every year

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Secondary Outcome

Defects of tooth structures measured by Developmental Defects of Enamel Index in the Primary and permanent dentition (DDE) yearly

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/05/04
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

preterm birth

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Exclusion Criteria

term birth

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Addresses

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    • Universitätsklinikum JenaZZMKPoliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Prof. Dr.  Roswitha  Heinrich-Weltzien 
    • Bachstr. 18
    • 07740  Jena
    • Germany
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    • Jena University HospitalZZMK - Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Dr.  Ina M.  Schüler 
    • Bachstraße 18
    • 07743  Jena
    • Germany
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    • Jena University HospitalZZMK - Poliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Dr.  Ina M.  Schüler 
    • Bachstraße 18
    • 07743  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • 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.