Trial document





This trial has been registered retrospectively.
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  DRKS00012993

Trial Description

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Title

Investigation into Influence of hypermineralized teeth on oral hygiene and caries prevalence for children and youth dependent on the severity of the disease

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Trial Acronym

MIH

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URL of the Trial

http://keine

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Brief Summary in Lay Language

The purpose of the present study is to investigate whether there was a severity-dependent relationship between the Molar Incisor Hypomineralisation (MIH) and Deciduous Molar Hypomineralisation (DMH) and the oral hygiene of the patients. It should be clarified whether there was an increase in plaque distribution (QHI) and increase of caries risk (dmft/DMFT) in relation to the severity of the enamel disorder and increased hypersensitivity of the affected teeth. In addition it should be examined whether the MIH/DMH disease has a negative effect on the diet of the patients.

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Brief Summary in Scientific Language

Cohort Study of 250 children and youth at the age of 3 to 15 years with hypomineralized teeth (MIH). The purpose of this study is to investigat a severity dependend relation to the oral hygiene and the nutrition of the patients.

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Organizational Data

  •   DRKS00012993
  •   2017/09/28
  •   [---]*
  •   yes
  •   Approved
  •   187/17-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K00.4 -  Disturbances in tooth formation
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Interventions/Observational Groups

  •   At the beginning of the investigation all dentistry findings were documented.
    All MIH affected teeth of the patients and all healthy teeth of the same group in both jaws were examined.
    At first the sensitivity of the teeth was tested with an air stimulus of a dental unit. Thereby an air stimulus was applied for 1-2 seconds at a distance of 1 cm to the facial surface of the tooth. The reaction of the patients was categorized with the Schiff-Cold-Air-Sensitivity-Scale (SCASS) and the Wong-Baker-Faces-Scale (WBFS)
    After that all teeth of the probands were dyed with a plaque-elevator to determine the Quigley-Hein-Index 1962 (QHI).
    At the end all probands and their legal representatives were questioned about dietary restrictions as a result of the disease.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The purpose of the present study is to investigate whether there was a severity-dependent relationship between the Molar Incisor Hypomineralisation (MIH) and Deciduous Molar Hypomineralisation (DMH) and the oral hygiene of the patients. It should be clarified whether there was an increase in plaque distribution (QHI) and increase of caries risk (dmft/DMFT) in relation to the severity of the enamel disorder and increased hypersensitivity of the affected teeth. In addition it should be examined whether the MIH/DMH disease has a negative effect on the diet of the patients.

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Secondary Outcome

With help of the collected data the DMFT (Decayed-Missing-Filled-Teeth-Index, Klein 1938) and the MIH-TNI (Würzburger-MIH-Treatement-Need-Index, Bekes 2016) can be determined.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/01/25
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

All patients had at least one affectet MIH tooth

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Exclusion Criteria

Patients with an orthodontic treatement; Patients which are not able or willing to tolarate the examination or to answer the qustions

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Kinderzahnarztpraxis Leo Löwenzahn
    • Mr.  MSc.  Markus  Ebel 
    • Odenthaler Strasse 132
    • 51465  Bergisch Gladbach
    • Germany
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    • Universitätszahnklinilk Leipzig
    • Mr.  Prof.  Christian  Hirsch 
    • Liebigstraße 10-14
    • 04103  Leipzig
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Kinderzaharztpraxis Leo Löwenzahn
    • Mr.  M. Sc.  Markus  Ebel 
    • Odenthaler Str. 132
    • 51465  Bergisch Gladbach
    • Germany
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    • Kinderzaharztpraxis Leo Löwenzahn
    • Mr.  M.Sc.  Markus  Ebel 
    • Odenthaler Str. 132
    • 51465  Bergisch Gladbach
    • Germany
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Sources of Monetary or Material Support

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    • Kinderzahnarztpraxis Leo Löwenzahn
    • Mr.  MSc.  Markus  Ebel 
    • Odenthaler Str. 132
    • 51465  Bergisch Gladbach
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/07/05
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Trial Publications, Results and other Documents

  •   Positives Votum
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* This entry means the parameter is not applicable or has not been set.