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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances

Conditions
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Orthodontics

Intervention / Treatment
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* Procedure: orthodontic treatment with customized archwires
* Procedure: orthodontic treatment with prefabricated archwires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CAD/CAM group, customized archwires | Procedure: orthodontic treatment with customized archwires<br>* orthodontic treatment with customized archwires<br>* Other names: SureSmile, CAD/CAM;|
| Active Comparator: 2<br>prefabricated archwires (superelastic) | Procedure: orthodontic treatment with prefabricated archwires<br>* orthodontic treatment with prefabricated archwires<br>* Other names: prefabricated archwires, conventional orthodontics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the orthodontic treatment (overall and every appointment) |  | every 6 weeks until the end of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality measured using a quality index (ABO-Score) |  |  | 
| Amount of root resorption comparing x-rays before and after the treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD/CAM, orthodontics, fixed appliance, tooth movement, Adverse Effects, Time Factors, Treatment Outcome