Tooth MovementNCT00871091
Study Investigating Tooth Movements With Conventional and Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) Supported Fixed Appliances
A study testing orthodontic treatment with customized archwires, orthodontic treatment with prefabricated archwires and orthodontic tx w/ conventional archwires+manual adjustments in people with Tooth Movement and Orthodontics, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Tooth Movement, Orthodontics
- What is being tested?
- orthodontic treatment with customized archwires, orthodontic treatment with prefabricated archwires and orthodontic tx w/ conventional archwires+manual adjustments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité - Universitätsmedizin Berlin
Berlin, 14197
About this study
Official title: 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.
- Conditions
- Tooth Movement, Orthodontics
- Being tested
- orthodontic treatment with customized archwires, orthodontic treatment with prefabricated archwires, orthodontic tx w/ conventional archwires+manual adjustments
- Keywords
- CAD/CAM, orthodontics, fixed appliance, tooth movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic treatment with customized archwiresProcedure or surgery
Also called SureSmile, CAD/CAM
customized arch wires depending on the amount of needed tooth movement
orthodontic treatment with prefabricated archwiresProcedure or surgery
Also called archwires, prefabricated, conventional orthodontic treatment
prefabricated archwires depending of the needed movement of the teeth
orthodontic tx w/ conventional archwires+manual adjustmentsProcedure or surgery
Also called manual adjustment, conventionel archwires
conventional archwires modified by manual adjustment, depending of needed correction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CAD/CAM group, customized archwires Receives: Procedure: orthodontic treatment with customized archwires |
| 2 | Active comparator | prefabricated archwires (superelastic) Receives: Procedure: orthodontic treatment with prefabricated archwires |
| 3 | Active comparator | prefabricated archwires with manual adjustments Receives: Procedure: orthodontic tx w/ conventional archwires+manual adjustments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of differences between resulted and shortest path of tooth movements in each patient
Measured: measurements every 14 days until end of treatment
Secondary outcomes (1)
Difference between resulted and shortest path of movements for each tooth
Measured: measurements every 14 days until end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startJan 2007
- Primary completionMay 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth MovementStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Paul-Georg Jost-Brinkmann, Prof, Study chair, Charite - Universitätsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871091
- Sponsor's protocol ID
- JO 207/4-1-4
- Status last verified
- Mar 2009
- First submitted
- 27 Mar 2009
- Last updated
- 30 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Investigating Tooth Movements With Conventional and CAD/CAM Supported Fixed Appliances
- ClinicalTrials.gov ID
- NCT00871091
- Acronym / sponsor ID
- JO 207/4-1-4
- Conditions
- Tooth Movement, Orthodontics
- Keywords
- CAD/CAM, orthodontics, fixed appliance, tooth movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2007
- Primary completion
- May 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: orthodontic treatment with customized archwiresCAD/CAM group, customized archwires |
| 2 | Active comparator | Procedure: orthodontic treatment with prefabricated archwiresprefabricated archwires (superelastic) |
| 3 | Active comparator | Procedure: orthodontic tx w/ conventional archwires+manual adjustmentsprefabricated archwires with manual adjustments |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthodontic treatment with customized archwiresAlso: SureSmile, CAD/CAMcustomized arch wires depending on the amount of needed tooth movement | Procedure or surgery | 1 |
| orthodontic treatment with prefabricated archwiresAlso: archwires, prefabricated, conventional orthodontic treatmentprefabricated archwires depending of the needed movement of the teeth | Procedure or surgery | 2 |
| orthodontic tx w/ conventional archwires+manual adjustmentsAlso: manual adjustment, conventionel archwiresconventional archwires modified by manual adjustment, depending of needed correction | Procedure or surgery | 3 |
Primary outcome
Sum of differences between resulted and shortest path of tooth movements in each patient
Time frame: measurements every 14 days until end of treatment
1 secondary outcome
Difference between resulted and shortest path of movements for each tooth
Time frame: measurements every 14 days until end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul-Georg Jost-Brinkmann, Prof study chair
Charite - Universitätsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic treatment with customized archwires, orthodontic treatment with prefabricated archwires and orthodontic tx w/ conventional archwires+manual adjustments in people with Tooth Movement and Orthodontics, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of differences between resulted and shortest path of tooth movements in each patient (time frame: measurements every 14 days until end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2009.