Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic Appliances
Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berlin, Germany
- Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
CAD/CAM group, customized archwires
|
orthodontic treatment with customized archwires
Other Names:
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Active Comparator: 2
prefabricated archwires (superelastic)
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orthodontic treatment with prefabricated archwires
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of the orthodontic treatment (overall and every appointment)
Time Frame: every 6 weeks until the end of the treatment
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every 6 weeks until the end of the treatment
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Secondary Outcome Measures
Outcome Measure |
|---|
|
Quality measured using a quality index (ABO-Score)
|
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Amount of root resorption comparing x-rays before and after the treatment
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Collaborators and Investigators
Investigators
- Study Chair: Paul-Georg Jost-Brinkmann, Prof, Charité - Universitätsmedizin
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JO 207/4-1-5
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