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

Orthodontics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00871026
• Other study ID #: JO 207/4-1-5
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2009
• Last updated: March 27, 2009
• Start date: March 2007
• Est. completion date: October 2010

Study information

• Verified date: March 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: October 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Orthodontics

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the orthodontic treatment (overall and every appointment)		every 6 weeks until the end of the treatment	No
Secondary	Quality measured using a quality index (ABO-Score)			No
Secondary	Amount of root resorption comparing x-rays before and after the treatment			No