Trial document




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  DRKS00011797

Trial Description

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Title

Randomized clincial trial on the efficacy of caries infiltration during treatment with fixed orthodontic appliances

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The success of the masking after orthodontic treatment presumably depends on the time of infiltration. The shorter the interval between the removal of the brackets and the infiltration treatment, the more satisfying the masking appears to be. This raises the question whether the aesthetic results can be optimized by an infiltration being performed during orthodontic treatment.
By an infiltration which is performed during orthodontic treatment, the progress of the lesion could be arrested at an earlier point of time as well. Thus the masking effect would presumably be more satisfying.
Until now there is no study answering this question.

We assume that the WSL which are infiltrated and subsequently fluoridated after their occurrence - during the orthodontic treatment with fixed appliance - will show a significantly smaller difference between the carious and healthy enamel than those are fluoridated during the orthodontic treatment and infiltrated only after removal of the fixed appliance.

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Organizational Data

  •   DRKS00011797
  •   2017/03/06
  •   [---]*
  •   yes
  •   Approved
  •   EK333/16, 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

  •   This is a monocentric, randomized, controlled study in split-mouth design. The teeth with the lesions are divided into two groups:

    Group A (test group): The WSLs will be infiltrated without removing the brackets with a low viscosity composite (ICON® infiltrant, DMG, Hamburg, Germany).

    At the beginning of the treatment all patients in both groups will receive nutritional and oral hygiene instruction .This includes the application applied once a week of a fluoride-containing Gel (elmex Gel, GABA, Loerrach, Germany).
  •   Group B (control group = standard therapy): The WSLs will be treated without removing the brackets with a fluoride varnish (Tiefenfluorid®, Humanchemie, Alfeld / Leine, Germany). The lesions which are still visible after removal of the brackets, will be treated directly with the caries-infiltration.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

In the planed randomized clinical study, three aspects should be tested -one week after treatment -concerning to the caries infiltration (test group) and sloely intensive fluoridation (control group = standard treatment) , of WSL developed during ongoing orthodontic treatment with fixed appliances:
1. the extent and severity of the WSL one week after treatment during the bracket treatment
2. The effect of masking of the caries-infiltration one week after treatment during the bracket treatment
3. The arresting or the progression of the infiltrated as well as the control lesions one week after the treatment during the bracket treatment

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Secondary Outcome

In the planed randomized clinical study, three aspects should be tested after removal of the brackets concerning to the caries infiltration (test group) and sloely intensive fluoridation (control group = standard treatment) , of WSL developed during ongoing orthodontic treatment with fixed appliances:
1. The extent and severity of the WSL after removal of the brackets
2. The effect of masking of the caries-infiltration after removal of the brackets
3. The arresting or the progression of the infiltrated as well as the control lesions after removal of the brackets

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/04/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

•Females and males at age between 12 and 70 years
•WSL developed throughout an orthodontic treatment with fixed devices in the region between teeth 14 and 24 also between 34 and 44
•Lesions with an ICDAS stage 1 or 2 (non-cavitated caries)
•Written consent of the patients or the parents after clarification

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Exclusion Criteria

•Incompatibility of one of the ingredients or contact allergies
•Cavitated lesions (ICDAS 3-6)
•Signs that the participant is not expected to comply with the protocol (e.g. lack of cooperation)
•Pregnancy or lactation period

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Addresses

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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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    • Kieferorthopädische Praxis Dr.med.dent. Youssef Cheaib
    • Syker Str. 15
    • 27211  Bassum
    • Germany
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    •   04241/7303
    •   04241/7101
    •   [---]*
    •   [---]*
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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Mr.  Dr.  Richard  Wierichs 
    • Pauwelsstr. 30,
    • 52074  Aachen
    • Germany
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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Mr.  Dr.  Richard  Wierichs 
    • Pauwelsstr. 30,
    • 52074  Aachen
    • Germany
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  • start of 1:1-Block address public-contact
    • Kieferorthopädische Praxis Dr.med.dent. Youssef Cheaib
    • Mr.  Fidaa  Shikh Ali 
    • Syker Str. 15
    • 27211  Bassum
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde,Universitätsklinikum der RWTH Aachen
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Prüfprotokoll
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* This entry means the parameter is not applicable or has not been set.