Trial document




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  DRKS00006215

Trial Description

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Title

Effect of Curodont TM Protect on prevention of artificial carious lesions of bovine enamel-an in-situ study

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Trial Acronym

Preventive effect of Curodont TM Protect

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Initial carious lesions in enamel may progress towards dentine caries with decay without any prevention. While an initial lesion can be arrested with preventive measurements, this is seldom the case in cavitations. The aim of this study is to evaluete whether different measurements are able to arest enamel lesions of further developement. Two different methods serve as test group 1: the established Duraphat varnish, 2: the newly developed Curodont Protect. The human saliva serves as control group. For each participant an individual removable resin appliance is prepared. In each appliance demineralized bovine enamel specimens (sterilized, BSE free) will be inserted. The specimen will be demineralized in a solution in order to simulate initial caries lesions.



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Brief Summary in Scientific Language

Initial carious lesions in enamel may progress towards dentine caries with decay without any prevention. While an initial lesion can be arrested with preventive measurements, this is seldom the case in cavitations. The aim of this study is to evaluate whether different measurements are able to arest enamel lesions of further developement. Two different methods serve as test group 1: the established Duraphat varnish, 2: the newly developed Curodont Protect. The human saliva serves as control group without any intervention. For each participant an individual removable resin appliance is prepared. In each appliance demineralized bovine enamel specimens (sterilized, BSE free) will be inserted. The specimen will be demineralized in a solution in order to simulate iinitial caries lesions.

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Organizational Data

  •   DRKS00006215
  •   2014/06/04
  •   [---]*
  •   yes
  •   Approved
  •   33/14, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   K02.0 -  Caries limited to enamel
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Interventions/Observational Groups

  •   Saliva (no intervention, natural saliva in patients´mouth, 4 weeks in total)
  •   Duraphat-Varnish (1x in 4 weeks, 4 weeks in total)
  •   Curodont Protect (2x week, 4 weeks in total)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Endpoint each arm: 4 weeks after wearing the appliance with specimen.
Endpoint of the study: due to the crossover design 12 weeks.
Measuring method: loss of mineral in enamel measured by micro-ct and fluoreszence.

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Secondary Outcome

Endpoint each arm: 4 weeks after wearing the appliance with specimen.
Endpoint of the study: due to the crossover design 12 weeks.
Measuring method: surface texture of specimen measured by scanning electron microscopy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/12/15
  •   9
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Age ≥ 18 years
low caries activity
Willing and able to attend the on-study visits and assessments
Willing and able to understand all study-related procedures and to follow the self-treatment instructions
informed consent

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Exclusion Criteria

Subjects with removable partial denture;
Subjects with fixed orthodontic appliances;
Subjects with current dental trauma or surgery;
Last applied high-concentration fluoride treatment (elmexgelee, etc.) < 2 weeks;
Smoker;
Subjects with bronchial asthma;
Evidence of tooth erosion;
History of head and neck illnesses (e.g. head/neck cancer);
Pregnant and breast-feeding women (no pregnancy test will be done for this clinical in situ study. Patient’s statement is considered as sufficient.);
Any pathology or concomitant medication affecting salivary flow or dry mouth: unstimulated < 0.2 ml/min;
Last taking of antibiotics < 2 months
Patients receiving medication known to stain teeth like tetracycline or chlorhexidine
high caries risk;
Concurrent participation in another clinical trial;
Subjects with known allergies//hypersensitivity towards agent of Curodont Protect or Duraphat varnish respectively.

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Addresses

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    • Medizinisches Zentrum für ZaMK, Abteilung für Kinderzahnheilkunde
    • Ms.  Prof. Dr.  Anahita  Jablonski-Momei 
    • Georg-Voigt-Str. 3
    • 35033  Marburg
    • Germany
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    • Zahnarztpraxis
    • Mr.  Dr.  Boris  Jablonski 
    • Kirschgarten 18
    • 35457  Lollar
    • Germany
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    •   06406-91620
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    • Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kinderzahnheilkunde
    • Ms.  Prof. Dr.  Anahita  Jablonski-Momeni 
    • Georg-Voigt Straße 3
    • 35033  Marburg
    • Germany
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    • Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kinderzahnheilkunde
    • Ms.  Prof. Dr.  Anahita  Jablonski-Momeni 
    • Georg-Voigt Straße 3
    • 35033  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Medizinisches Zentrum für ZMK, Abteilung für Kinderzahnheilkunde
    • Ms.  Pro.f Dr.  Anahita   Jablonski-Momeni 
    • Georg-Voigt Straße 3
    • 35033  Marburg
    • Germany
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    • Zahnarztpraxis
    • Mr.  Dr.  Boris  Jablonski 
    • Kirschgarten 18
    • 35457  Lollar
    • Germany
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    •   [---]*
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    • Präsidentin der Deutschen Gesellschaft für Präventivzahnmedizin e.V. Justus-Liebig-Universität Gießen
    • Ms.  Prof. Dr.  Carolina  Ganß 
    • Schlangenzahl 14
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/15
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Trial Publications, Results and other Documents

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