This trial is active, not recruiting.

Condition orthodontics
Treatments orthodontic treatment with customized archwires, orthodontic treatment with prefabricated archwires
Sponsor Charite University, Berlin, Germany
Start date March 2007
End date March 2010
Trial size 160 participants
Trial identifier NCT00871026, JO 207/4-1-5


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
CAD/CAM group, customized archwires
orthodontic treatment with customized archwires SureSmile, CAD/CAM
orthodontic treatment with customized archwires
(Active Comparator)
prefabricated archwires (superelastic)
orthodontic treatment with prefabricated archwires prefabricated archwires, conventional orthodontics
orthodontic treatment with prefabricated archwires

Primary Outcomes

Duration of the orthodontic treatment (overall and every appointment)
time frame: every 6 weeks until the end of the treatment

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 11 years up to 30 years old.

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

Additional Information

Official title Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.