Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic Appliances

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Charité University Medicine Berlin

Status

Unknown

Conditions

Orthodontics

Treatments

Procedure: orthodontic treatment with prefabricated archwires
Procedure: orthodontic treatment with customized archwires

Study type

Interventional

Funder types

Other

Identifiers

NCT00871026
JO 207/4-1-5

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

11 to 30 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 2 patient groups

1
Experimental group
Description:
CAD/CAM group, customized archwires
Treatment:
Procedure: orthodontic treatment with customized archwires
2
Active Comparator group
Description:
prefabricated archwires (superelastic)
Treatment:
Procedure: orthodontic treatment with prefabricated archwires

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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