Clinical trial NCT00871026: Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic Appliances
Official title: Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontics
Keywords: CAD/CAM
orthodontics
fixed appliance
tooth movement
Adverse Effects
Time Factors
Treatment Outcome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 160
Sex: ALL
Minimum age (years): 11
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Duration of the orthodontic treatment (overall and every appointment)
timeFrame: every 6 weeks until the end of the treatment
Secondary outcomes:
measure: Quality measured using a quality index (ABO-Score)
measure: Amount of root resorption comparing x-rays before and after the treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite - Universitätsmedizin
name: Paul-Georg Jost-Brinkmann, Prof
role: STUDY_CHAIR
References: