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Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic 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:
NCT00871026
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.
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
Orthodontics Procedure: orthodontic treatment with customized archwires Procedure: orthodontic treatment with prefabricated archwires

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Duration of the orthodontic treatment (overall and every appointment) [ Time Frame: every 6 weeks until the end of the treatment ]

Secondary Outcome Measures:
  • Quality measured using a quality index (ABO-Score)
  • Amount of root resorption comparing x-rays before and after the treatment

Enrollment: 160
Study Start Date: March 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CAD/CAM group, customized archwires
Procedure: orthodontic treatment with customized archwires
orthodontic treatment with customized archwires
Other Name: SureSmile, CAD/CAM
Active Comparator: 2
prefabricated archwires (superelastic)
Procedure: orthodontic treatment with prefabricated archwires
orthodontic treatment with prefabricated archwires
Other Name: prefabricated archwires, conventional orthodontics

Detailed Description:

In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction. At the moment there is no tool, that allows to predict the treatment result. Using conventional orthodontic treatment methods the orthodontist approaches the final result using the trial-and-error-method, bending the wires in each appointment until both, patient and orthodontist are satisfied. Usually there is only a general treatment plan, but not a detailed treatment plan of each tooth movement. This leads to a longer treatment time and causes more costs. Besides the probability of side effects (such as caries root resorption) increases with the duration of the treatment.

In this case the chosen technology is called SureSmile(R)(by OraMetrix). SureSmile allows the collection 3D-data intraorally and from plaster models, it gives a possibility of computer aided treatment planing (Computer Aided Design) and the manufacturing of customized archwires (Computer Aided Manufacturing).

This new technology promises to reduce the time and effort of an orthodontic treatment providing predictability and quality also minimizing negative side effects.

This technology could - using this diagnostic 3D-system - help to understand orthodontic movement and basic principles of the remodeling of the periodontium and to improve orthodontic mechanics.

  Eligibility

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Ages Eligible for Study:   11 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • treatment with fixed orthodontic appliances is indicated
  • complete secondary dentition
  • age: 11-30
  • in good general health
  • patient is informed about study and agrees to participate

Exclusion Criteria:

  • 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): NCT00871026


Locations
Germany
Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
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: NCT00871026     History of Changes
Other Study ID Numbers: JO 207/4-1-5
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
Adverse Effects
Time Factors
Treatment Outcome