Study Investigating Tooth Movements With Conventional and... | NCT00871091

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

NCT00871091

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Mar 30, 2009Estimated

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Tooth Movement
Orthodontics

Interventions

orthodontic treatment with customized archwires
orthodontic treatment with prefabricated archwires
orthodontic tx w/ conventional archwires+manual adjustments

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

May 2009Estimated

Completion Date

Jun 2009Estimated

First Submitted Date

Mar 27, 2009

First Submission Date that Met QC Criteria

Mar 27, 2009

First Posted Date

Mar 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2009

Last Update Posted Date

Mar 30, 2009Estimated

Name	Class
German Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
orthodontic treatment with customized archwires	Procedure	customized arch wires depending on the amount of needed tooth movement	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul-Georg Jost-Brinkmann, Prof	Charite - Universitätsmedizin	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin		Berlin		14197	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms