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 because the information has not been verified recently.
Verified March 2009 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00871091
First received: March 27, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between resulted and shortest path of movements for each tooth [ Time Frame: measurements every 14 days until end of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 27, 2009
Last Updated: March 27, 2009
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 17, 2014