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Study Investigating Tooth Movements With Conventional and Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) Supported Fixed Appliances

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ClinicalTrials.gov Identifier: NCT00871091
Recruitment Status : Unknown
Verified March 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2009
Last Update Posted : March 30, 2009
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Charite University, Berlin, Germany

Brief Summary:

In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction.

May treatment be improved with customized archwires?

Study hypotheses:

  • By using CAD/CAM in planning and fabrication of customized archwires, unnecessary tooth movements can be avoided and teeth can be moved on their direct path to the intended position.
  • The application of CAD/CAM improves reproducibility, efficiency, and quality of orthodontic treatment.

Condition or disease Intervention/treatment Phase
Tooth Movement Orthodontics Procedure: orthodontic treatment with customized archwires Procedure: orthodontic treatment with prefabricated archwires Procedure: orthodontic tx w/ conventional archwires+manual adjustments Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Investigating Tooth Movements With Conventional and CAD/CAM Supported Fixed Appliances
Study Start Date : January 2007
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Experimental: 1
CAD/CAM group, customized archwires
Procedure: orthodontic treatment with customized archwires
customized arch wires depending on the amount of needed tooth movement
Other Names:
  • SureSmile
  • CAD/CAM

Active Comparator: 2
prefabricated archwires (superelastic)
Procedure: orthodontic treatment with prefabricated archwires
prefabricated archwires depending of the needed movement of the teeth
Other Names:
  • archwires, prefabricated
  • conventional orthodontic treatment

Active Comparator: 3
prefabricated archwires with manual adjustments
Procedure: orthodontic tx w/ conventional archwires+manual adjustments
conventional archwires modified by manual adjustment, depending of needed correction
Other Names:
  • manual adjustment
  • conventionel archwires




Primary Outcome Measures :
  1. Sum of differences between resulted and shortest path of tooth movements in each patient [ Time Frame: measurements every 14 days until end of treatment ]

Secondary Outcome Measures :
  1. Difference between resulted and shortest path of movements for each tooth [ Time Frame: measurements every 14 days until end of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • treatment of front teeth with fixed orthodontic appliances is indicated
  • complete secondary dentition
  • age: 18-35
  • in healthy general condition
  • patient is informed about study and agrees to participate

Exclusion Criteria:

  • treatment of premolars and molars is necessary
  • syndromes affecting bones and teeth
  • cleft lip and palate
  • inflammation or reduction (more than 50%) of periodontium
  • intake of drugs affecting tooth movement and bone formation
  • disturbance of bone formation
  • disturbance of thyroidal function
  • pregnancy
  • participation in additional study affecting oral hygiene
  • former therapy with ionized radiation or cytostatic drugs
  • caries (active phase)
  • alcohol dependency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871091


Locations
Germany
Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
Berlin, Germany, 14197
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Investigators
Study Chair: Paul-Georg Jost-Brinkmann, Prof Charite - Universitätsmedizin

Responsible Party: Paul-G. Jost-Brinkmann, Prof. Dr., Charité - Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00871091     History of Changes
Other Study ID Numbers: JO 207/4-1-4
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Keywords provided by Charite University, Berlin, Germany:
CAD/CAM
orthodontics
fixed appliance
tooth movement