OrthodonticsNCT00871026
Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) - Based Planning and Creation of Orthodontic Appliances
A study testing orthodontic treatment with customized archwires and orthodontic treatment with prefabricated archwires in people with 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 11 to 30 years
- Conditions the study is for
- Orthodontics
- What is being tested?
- orthodontic treatment with customized archwires and orthodontic treatment with prefabricated archwires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Oct 2010
- 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 11 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- treatment with fixed orthodontic appliances is indicated
- complete secondary dentition
- age: 11-30
- in good general health
- patient is informed about study and agrees to participate
Who cannot join
- 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
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- 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
About this study
Official title: Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic 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.
Read the detailed description
In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction. At the moment there is no tool, that allows to predict the treatment result. Using conventional orthodontic treatment methods the orthodontist approaches the final result using the trial-and-error-method, bending the wires in each appointment until both, patient and orthodontist are satisfied. Usually there is only a general treatment plan, but not a detailed treatment plan of each tooth movement. This leads to a longer treatment time and causes more costs. Besides the probability of side effects (such as caries root resorption) increases with the duration of the treatment.
In this case the chosen technology is called SureSmile(R)(by OraMetrix). SureSmile allows the collection 3D-data intraorally and from plaster models, it gives a possibility of computer aided treatment planing (Computer Aided Design) and the manufacturing of customized archwires (Computer Aided Manufacturing).
This new technology promises to reduce the time and effort of an orthodontic treatment providing predictability and quality also minimizing negative side effects.
This technology could - using this diagnostic 3D-system - help to understand orthodontic movement and basic principles of the remodeling of the periodontium and to improve orthodontic mechanics.
- Conditions
- Orthodontics
- Being tested
- orthodontic treatment with customized archwires, orthodontic treatment with prefabricated archwires
- Keywords
- CAD/CAM, orthodontics, fixed appliance, tooth movement, Adverse Effects, Time Factors, Treatment Outcome
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
orthodontic treatment with customized archwires
orthodontic treatment with prefabricated archwiresProcedure or surgery
Also called prefabricated archwires, conventional orthodontics
orthodontic treatment with prefabricated archwires
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the orthodontic treatment (overall and every appointment)
Measured: every 6 weeks until the end of the treatment
Secondary outcomes (2)
Quality measured using a quality index (ABO-Score)
Amount of root resorption comparing x-rays before and after the 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 startMar 2007
- Primary completionMar 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Paul-Georg Jost-Brinkmann, Prof, Study chair, Charite - Universitätsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871026
- Sponsor's protocol ID
- JO 207/4-1-5
- 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
- Randomized Controlled Clinical Study Comparing Conventional and CAD/CAM-Based Treatment With Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT00871026
- Acronym / sponsor ID
- JO 207/4-1-5
- Conditions
- Orthodontics
- Keywords
- CAD/CAM, orthodontics, fixed appliance, tooth movement, Adverse Effects, Time Factors, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Oct 2010 (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.
Detailed description
In orthodontics, conventional fixed appliances, usually consisting of prefabricated components, require step-by-step adjustment in order to move teeth in the planned direction. At the moment there is no tool, that allows to predict the treatment result. Using conventional orthodontic treatment methods the orthodontist approaches the final result using the trial-and-error-method, bending the wires in each appointment until both, patient and orthodontist are satisfied. Usually there is only a general treatment plan, but not a detailed treatment plan of each tooth movement. This leads to a longer treatment time and causes more costs. Besides the probability of side effects (such as caries root resorption) increases with the duration of the treatment.
In this case the chosen technology is called SureSmile(R)(by OraMetrix). SureSmile allows the collection 3D-data intraorally and from plaster models, it gives a possibility of computer aided treatment planing (Computer Aided Design) and the manufacturing of customized archwires (Computer Aided Manufacturing).
This new technology promises to reduce the time and effort of an orthodontic treatment providing predictability and quality also minimizing negative side effects.
This technology could - using this diagnostic 3D-system - help to understand orthodontic movement and basic principles of the remodeling of the periodontium and to improve orthodontic mechanics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| 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) |
Who may qualify
- Ages
- 11 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- treatment with fixed orthodontic appliances is indicated
- complete secondary dentition
- age: 11-30
- in good general health
- patient is informed about study and agrees to participate
Key exclusion criteria (11 listed)
- 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
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/CAMorthodontic treatment with customized archwires | Procedure or surgery | 1 |
| orthodontic treatment with prefabricated archwiresAlso: prefabricated archwires, conventional orthodonticsorthodontic treatment with prefabricated archwires | Procedure or surgery | 2 |
Primary outcome
Duration of the orthodontic treatment (overall and every appointment)
Time frame: every 6 weeks until the end of the treatment
2 secondary outcomes
Quality measured using a quality index (ABO-Score)
Amount of root resorption comparing x-rays before and after the 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 and orthodontic treatment with prefabricated archwires in people with 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 11 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?
Duration of the orthodontic treatment (overall and every appointment) (time frame: every 6 weeks until the end of the 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; AzTrials last refreshed its copy on 28 Oct 2026.