Trial document




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  DRKS00009760

Trial Description

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Title

Randomized clinical study on the infiltration of enamel mineralization disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Topic: The effect of infiltration (Icon; DMG, Hamburg) on uncavitated hypomineralized defects will be evaluated with the help of digital photoanalysis and the process of the treatment will be assessed and optimized.
Background: Infiltration is a relative new treatment option.
Treatment: Through the treatment the hypomineralisations will be masked and the therefore the aesthetics of the teeth will be improved.
Patients: Patients between 6 and 70 years and mineralization defects (Fluorosis and Hypomeneralisation) on their upper and lower teeth will be treated in the Clinic of Operative Dentistry, Periodontology and Preventive Dentistry, RWTH Aachen University as well as in a private dental office.
Aim: Improvement of aesthetics
Hypothesis: Through the treatment the hypomineralisations will be masked and the therefore the aesthetics of the teeth will be improved.

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Brief Summary in Scientific Language

There are several therapeutic options (bleaching, microabrasion, sealing, restorations) for the aesthetic improvement of teeth with enamel hypomineralization or fluorosis. Infiltration (Icon; DMG, Hamburg) is a relative new treatment option.Therefore the main purpose of this study is the subjective and objective evaluation of the effect of the number of etching steps before infiltration on the appearance before and after treatment of teeth with MIH and fluorosis. Patients between 6 and 70 years with mineralisation defects (Fluorosis and Hypomineralisation) on their front teeth will be treated in the Clinic of Operative Dentistry, Periodontology and Preventive Dentistry, RWTH Aachen University and in a private dental office.

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Organizational Data

  •   DRKS00009760
  •   2016/03/22
  •   [---]*
  •   yes
  •   Approved
  •   187/14, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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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

  •   Evidence that the mineralisation defects (Fluorosis and/or Hypomineralisation)will be masked after infiltration. The Icon-Etch will be applied only one time.
  •   Evidence that the mineralisation defects (Fluorosis and/or Hypomineralisation)will be masked after infiltration. The Icon-Etch will be applied three time.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Success of defects ‘masking seven days after Infiltration.
- standardized questionnaire before and after treatment
- digital analysis of photographs before and after treatment.

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Secondary Outcome

Success of defects ‘masking seven days after Infiltration. Reevaluations will be performed every 6 months.
- digital analysis of photographs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2016/04/01
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   70   Years
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Additional Inclusion Criteria

- Fluorosis or Hypomineralisation(teeth: 15-25, 35-45)
- Patient between 6 and 70 years
- Written concern of the patients or patients and their legal guardians

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Exclusion Criteria

- Allergies to ICON’s compounds
- Teeth with enamel cavitations
- Pregnancy or breastfeeding
- Signals that the patient cannot follow the schedule of the study (e.g. uncooperative patients)

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Addresses

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    • Klinik für Zahnerhaltung, Parodontologie und Präventive ZahnheilkundeUniversitätsklinikum der RWTH Aachen
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Klinik für Zahnerhaltung, Parodontologie und Präventive ZahnheilkundeUniversitätsklinikum der RWTH Aachen
    • Ms.  Dr. med. dent.  Marina  Petrou 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum der RWTH Aachen
    • Mr.  Dr. med. dent.  Richard  Wierichs 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Klinik für Zahnerhaltung, Parodontologie und Präventive ZahnheilkundeUniversitätsklinikum der RWTH Aachen
    • Ms.  Dr. med. dent.  Marina  Petrou 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum der RWTH Aachen
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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