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

March 27, 2009 updated by: Charite University, Berlin, Germany

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14197
        • Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CAD/CAM group, customized archwires
Procedure: orthodontic treatment with customized archwires
customized arch wires depending on the amount of needed tooth movement
Other Names:
  • SureSmile
  • CAD/CAM
Active Comparator: 2
prefabricated archwires (superelastic)
Procedure: orthodontic treatment with prefabricated archwires
prefabricated archwires depending of the needed movement of the teeth
Other Names:
  • archwires, prefabricated
  • conventional orthodontic treatment
Active Comparator: 3
prefabricated archwires with manual adjustments
Procedure: orthodontic tx w/ conventional archwires+manual adjustments
conventional archwires modified by manual adjustment, depending of needed correction
Other Names:
  • manual adjustment
  • conventionel archwires

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Research Foundation

Investigators

  • Study Chair: Paul-Georg Jost-Brinkmann, Prof, Charité - Universitätsmedizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

March 30, 2009

Last Update Submitted That Met QC Criteria

March 27, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JO 207/4-1-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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