Trial document





This trial has been registered retrospectively.
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  DRKS00024350

Trial Description

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Title

Is a quality improvement in orthodontics with the aid of modern 3D scanners possible?

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Trial Acronym

KFO-3DSCAN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Orthodontic treatment of malocclusion can be corrected with so-called multi-bracket devices of different manufacturers. With doing this, brackets are bonded to teeth at exact defined positions and then connected with orthodontic wires.

A manual positioning of the brackets requires high precision. To ease positioning, transmission guides were developed. Newer developments promise a simplified, faster and more exact treatment by application of individualized brackets.

Aim of this study was, to compare both treatment techniques with each other.

For this purpose, patients were split in two groups. One group was treated with conventional brackets. In the other group, the ideal position of the brackets was calculated and with the aid of a transmission tool glued to the corresponding position on the teeth. In advance, the brackets applied in this group were individualized based on an individually simulated ideal treatment result. Both groups were compared concerning total treatment duration, number of appointments, number of lost or repositioned brackets, the number of wires used during treatment, the number of additionally applied wire bending and data from X-ray and model analysis. Additionally, a comparison between the previously simulated ideal treatment goal and the actual achieved result was done, to evaluate the clinical realization.

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Brief Summary in Scientific Language

Nowadays, CAD/CAM technologies enrich orthodontics in several ways. While they are commonly used for diagnoses and treatment planning, they can also be applied to create individualized bracket systems.

The purpose of this prospective randomized study was to evaluate the clinical effectiveness of a customized bracket system and its comparison with directly bonded conventional self-ligating brackets treatment. Patients were separated into two groups, one treated with direct bonded self-ligating brackets (Damon, Ormco, USA) and the other one treated with indirect bonded customized brackets (Insignia™, Ormco, USA). Overall treatment time, number of treatment appointments, number of lost or repositioned brackets, number of arch wires and wire bends, cephalometric analyses, and ABO scores were compared. In addition, superimpositions of the virtual set-ups and the treatment results of the CAD/CAM group was performed to evaluate the clinical realization of the treatment planning.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

The data will be published in a scientific publication.

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Organizational Data

  •   DRKS00024350
  •   2021/02/15
  •   [---]*
  •   yes
  •   Approved
  •   312-15, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   K07.3 -  Anomalies of tooth position
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Interventions/Observational Groups

  •   Treatment with Insignia
  •   Treatment with Damon
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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)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

After completion of treatment the following data is summarized for each patient: overall treatment time, number of treatment appointments, number of lost or repositioned brackets, number of arch wires and wire bends, cephalometric analyses, and ABO scores were compared. Superimpositions of the virtual set-ups and the treatment results of the CAD/CAM group was performed to evaluate the clinical realization of the treatment planning.

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Secondary Outcome

N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/07/13
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1) Indication of orthodontic treatment
2) All permanent teeth needed to be erupted (except for third molars)
3) No extractions needed for treatment
4) No orthognathic surgery necessary
5) Extent of malocclusion <4 mm in the molar region

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Exclusion Criteria

1) Missing of permanent teeth in adolescents and adults
2) Extraction cases
3) Patients with orthodontic-orthognathic surgery
4) Extent of malocclusion >4 mm in the molar region

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Poliklinik für Kieferorthopädie, LMU Klinikum
    • Ms.  Prof. Dr. med. dent.  Andrea  Wichelhaus 
    • Goethestrasse 70
    • 80336  München
    • Germany
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    • Poliklinik für Kieferorthopädie, LMU Klinikum
    • Ms.  Prof. Dr. med. dent.  Andrea  Wichelhaus 
    • Goethestrasse 70
    • 80336  München
    • Germany
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    • Poliklinik für Kieferorthopädie, LMU Klinikum
    • Ms.  Dr. med. dent.  Lena  Seitz 
    • Goethestrasse 70
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik für Kieferorthopädie, LMU Klinikum
    • Ms.  Prof. Dr. med. dent.  Andrea  Wichelhaus 
    • Goethestrasse 70
    • 80336  München
    • Germany
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    • Ormco Europe B.V.
    • Basicweg 20
    • 3821  Amersfoort
    • Netherlands
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Status

  •   Recruiting complete, follow-up complete
  •   2019/08/27
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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.