NCT00871091

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

March 27, 2009

Last Update Submit

March 27, 2009

Conditions

Keywords

CAD/CAMorthodonticsfixed appliancetooth movement

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

EXPERIMENTAL

CAD/CAM group, customized archwires

Procedure: orthodontic treatment with customized archwires

2

ACTIVE COMPARATOR

prefabricated archwires (superelastic)

Procedure: orthodontic treatment with prefabricated archwires

3

ACTIVE COMPARATOR

prefabricated archwires with manual adjustments

Procedure: orthodontic tx w/ conventional archwires+manual adjustments

Interventions

customized arch wires depending on the amount of needed tooth movement

Also known as: SureSmile, CAD/CAM
1

prefabricated archwires depending of the needed movement of the teeth

Also known as: archwires, prefabricated, conventional orthodontic treatment
2

conventional archwires modified by manual adjustment, depending of needed correction

Also known as: manual adjustment, conventionel archwires
3

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin

Berlin, 14197, Germany

Location

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Paul-Georg Jost-Brinkmann, Prof

    Charite - Universitätsmedizin

    STUDY CHAIR

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

Locations