Overview

This trial is active, not recruiting.

Conditions tooth movement, orthodontics
Treatments orthodontic treatment with customized archwires, orthodontic treatment with prefabricated archwires, orthodontic tx w/ conventional archwires+manual adjustments
Sponsor Charite University, Berlin, Germany
Collaborator German Research Foundation
Start date January 2007
End date May 2009
Trial size 32 participants
Trial identifier NCT00871091, JO 207/4-1-4

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
CAD/CAM group, customized archwires
orthodontic treatment with customized archwires SureSmile
customized arch wires depending on the amount of needed tooth movement
(Active Comparator)
prefabricated archwires (superelastic)
orthodontic treatment with prefabricated archwires archwires, prefabricated
prefabricated archwires depending of the needed movement of the teeth
(Active Comparator)
prefabricated archwires with manual adjustments
orthodontic tx w/ conventional archwires+manual adjustments manual adjustment
conventional archwires modified by manual adjustment, depending of needed correction

Primary Outcomes

Measure
Sum of differences between resulted and shortest path of tooth movements in each patient
time frame: measurements every 14 days until end of treatment

Secondary Outcomes

Measure
Difference between resulted and shortest path of movements for each tooth
time frame: measurements every 14 days until end of treatment

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Pilot Study Investigating Tooth Movements With Conventional and CAD/CAM Supported Fixed Appliances
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.