Study Investigating Tooth Movements With Conventional and Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) Supported Fixed Appliances

Orthodontics Clinical Trial

Official title:

Pilot Study Investigating Tooth Movements With Conventional and CAD/CAM Supported Fixed Appliances

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00871091
• Other study ID #: JO 207/4-1-4
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2009
• Last updated: March 27, 2009
• Start date: January 2007
• Est. completion date: June 2009

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• treatment of front teeth with fixed orthodontic appliances is indicated

• complete secondary dentition

• age: 18-35

• in healthy general condition

• patient is informed about study and agrees to participate

Exclusion Criteria:

• treatment of premolars and molars is necessary

• 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: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Orthodontics
• Tooth Movement

Intervention

Procedure:
• orthodontic treatment with customized archwires
customized arch wires depending on the amount of needed tooth movement
• orthodontic treatment with prefabricated archwires
prefabricated archwires depending of the needed movement of the teeth
• orthodontic tx w/ conventional archwires+manual adjustments
conventional archwires modified by manual adjustment, depending of needed correction

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of differences between resulted and shortest path of tooth movements in each patient		measurements every 14 days until end of treatment	No
Secondary	Difference between resulted and shortest path of movements for each tooth		measurements every 14 days until end of treatment	No