Trial document




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  DRKS00005628

Trial Description

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Title

Oral health and nutritional status of preterm infants compared to term infants

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Trial Acronym

Oral health of preterms

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URL of the Trial

http://keine vorhanden

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Brief Summary in Lay Language

The premature birth is a major problem in obstetrics and the most important risk factor for perinatal mortality and morbidity. Additional preterm children have oral health problems such as tooth developmental problems, tooth eruption disorders and jaw abnormalities. One of the most common complications are tooth structure defects in form of enamel hypoplasia in the deciduous and permanent dentition, which are associated with a higher caries prevalence. Therefor, the early diagnosis of enamel defects in the deciduous and permanent dentition at the individual and population level is significant. In Germany, there are currently no data on oral health and nutritional status of preterm infants compared to term infants in the deciduous and permanent dentition. To give preventive and therapeutic recommendations for this specific group of patients and to make statements about the multivariate etiology and the impact on the dental development of this children it is neccessary to examine this specific group. The aim of this prospective case-control study with a randomized patient selection is to capture the oral health (structural disorders of the dental hard tissues, caries) and the nutritional status of preterm infants compared to term infants in the deciduous and permanent dentition. The first hypothesis is that in the group of preterm infants the prevalence of developmental defects of enamel is higher compared to the group of term infants. The second hypothesis is that in children with tooth developmental disorders the caries experience and caries prevalence is higher. Therefor, 3- to 4-year-old and 7- to 9-year-old preterm and term children will be randomized selected and examined. Additional all factors which could have an impact on the tooth development will be recorded (reports of the gynecologist and paediatrician).

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Brief Summary in Scientific Language

The aim of this prospective case-control study with a randomized patient selection is to capture the oral health (structural disorders of tooth structure, dental caries, periodontal diseases, dento-facial anomalies) and the nutritional status of preterm infants compared to term infants in the deciduous and permanent dentition to give preventive and therapeutic recommendations for this specific group of patients and to make statements about the multivariate etiology of dental developmental disorders.

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Organizational Data

  •   DRKS00005628
  •   2014/01/24
  •   [---]*
  •   yes
  •   Approved
  •   3940-12/13, 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

  •   K00-K14 -  Diseases of oral cavity, salivary glands and jaws
  •   K00.9 -  Disorder of tooth development, unspecified
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Interventions/Observational Groups

  •   Study of 3 - to 4-year-old and 7 - to 9-year-old preterm children (<37.SSW, <2500g) which have been randomly selected from the patient population of the children clinic with regard to dental status (dmft, dmfs DDE), BMI (body weight / height), retrospective acquisition of data which could affect the dental development: week of gestation, pregnancy problems (preeclampsia , diabetes, hypertension, infections, medication, type of birth), U-test results, APGAR score
  •   Study of 3 - to 4-year-old and 7 - to 9-year-old mature infants which have been randomly selected from the patient population of the dental clinic with regard to dental status (dmft, dmfs DDE), BMI (body weight, height), detection of pregnancy problems (preeclmapsia, diabetes, hypertension, infections, medication, type of birth), results of the U-tests, APGAR score, systemic diseases, medication
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Screening
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Examination of decayed, missing or filled teeth and surfaces (dmft/dmfs), Categorized determination of structural defetcs using the index of dental development disturbances of the enamel - Developmental Defects of Enamel - Index (DDE) and comparison of the prevalence of DDE between both groups

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Secondary Outcome

Examination of the BMI

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/03
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   9   Years
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Additional Inclusion Criteria

Preterm infants <37 SSW, low birth weight <2500 g, full-term infants,
3 - 4 - year-old children and 7-9 - year-old children from the group preterm and term infants

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Exclusion Criteria

no

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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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    • Universitätsklinikum JenaKlinik für Kinder- und JugendmedizinSektion Neonatologie und Pädiatrische Intensivmedizin
    • Mr.  Prof. Dr.  Hans  Proquitté 
    • Kochstr. 2
    • 07740  Jena
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum JenaZZMKPoliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Prof. Dr.  Roswitha  Heinrich-Weltzien 
    • Bachstr. 18
    • 07740  Jena
    • Germany
    end of 1:1-Block address scientific-contact
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  • start of 1:1-Block address public-contact
    • Universitätsklinikum JenaZZMKPoliklinik für Präventive Zahnheilkunde und Kinderzahnheilkunde
    • Ms.  Prof. Dr.  Roswitha  Heinrich-Weltzien 
    • Bachstr. 18
    • 07740  Jena
    • Germany
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Sources of Monetary or Material Support

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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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Status

  •   Recruiting ongoing
  •   [---]*
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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.