Study Investigating Tooth Movements With Conventional and Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) Supported Fixed Appliances
Pilot Study Investigating Tooth Movements With Conventional and CAD/CAM Supported Fixed Appliances
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 30, 2009
March 1, 2009
2.3 years
March 27, 2009
March 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sum of differences between resulted and shortest path of tooth movements in each patient
measurements every 14 days until end of treatment
Secondary Outcomes (1)
Difference between resulted and shortest path of movements for each tooth
measurements every 14 days until end of treatment
Study Arms (3)
1
EXPERIMENTALCAD/CAM group, customized archwires
2
ACTIVE COMPARATORprefabricated archwires (superelastic)
3
ACTIVE COMPARATORprefabricated archwires with manual adjustments
Interventions
customized arch wires depending on the amount of needed tooth movement
prefabricated archwires depending of the needed movement of the teeth
conventional archwires modified by manual adjustment, depending of needed correction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- German Research Foundationcollaborator
Study Sites (1)
Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
Berlin, 14197, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul-Georg Jost-Brinkmann, Prof
Charite - Universitätsmedizin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 27, 2009
First Posted
March 30, 2009
Study Start
January 1, 2007
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
March 30, 2009
Record last verified: 2009-03