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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871091
First Posted: March 30, 2009
Last Update Posted: March 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by:
Charite University, Berlin, Germany
  Purpose

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 Intervention
Tooth Movement Orthodontics Procedure: orthodontic treatment with customized archwires Procedure: orthodontic treatment with prefabricated archwires Procedure: orthodontic tx w/ conventional archwires+manual adjustments

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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

Estimated Enrollment: 32
Study Start Date: January 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: March 27, 2009
First Posted: March 30, 2009
Last Update Posted: March 30, 2009
Last Verified: March 2009

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