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

NCT ID: NCT00871091

Last Updated: 2009-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Movement Orthodontics

Keywords

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CAD/CAM orthodontics fixed appliance tooth movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

CAD/CAM group, customized archwires

Group Type EXPERIMENTAL

orthodontic treatment with customized archwires

Intervention Type PROCEDURE

customized arch wires depending on the amount of needed tooth movement

2

prefabricated archwires (superelastic)

Group Type ACTIVE_COMPARATOR

orthodontic treatment with prefabricated archwires

Intervention Type PROCEDURE

prefabricated archwires depending of the needed movement of the teeth

3

prefabricated archwires with manual adjustments

Group Type ACTIVE_COMPARATOR

orthodontic tx w/ conventional archwires+manual adjustments

Intervention Type PROCEDURE

conventional archwires modified by manual adjustment, depending of needed correction

Interventions

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orthodontic treatment with customized archwires

customized arch wires depending on the amount of needed tooth movement

Intervention Type PROCEDURE

orthodontic treatment with prefabricated archwires

prefabricated archwires depending of the needed movement of the teeth

Intervention Type PROCEDURE

orthodontic tx w/ conventional archwires+manual adjustments

conventional archwires modified by manual adjustment, depending of needed correction

Intervention Type PROCEDURE

Other Intervention Names

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SureSmile CAD/CAM archwires, prefabricated conventional orthodontic treatment manual adjustment conventionel archwires

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité - Universitätsmedizin Berlin

Principal Investigators

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Paul-Georg Jost-Brinkmann, Prof

Role: STUDY_CHAIR

Charite - Universitätsmedizin

Locations

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

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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JO 207/4-1-4

Identifier Type: -

Identifier Source: org_study_id