Dental BondingNCT04683874
Transfer Accuracy of 3D-printed Indirect Bonding Trays
A study testing 3D printed tray in people with Dental Bonding, run by Thorsten Gruenheid at 1 site in United States.
Trial summary
This study evaluates the transfer accuracy of 3D-printed trays for indirect bonding of orthodontic brackets in vivo. Accurate placement of orthodontic brackets at the beginning of treatment improves treatment efficiency and shortens treatment time. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Dental Bonding
- What is being tested?
- 3D printed tray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 29 Sep 2021
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults and children (ages 12 years and older) who are in the permanent dentition.
Who cannot join
- Less than 12 years of age, primary or mixed dentition, or bonded orthodontic appliances present, prosthetic restorations on the facial surfaces of teeth, craniofacial anomalies, and dental anomalies such as malformation, microdontia, or severe attrition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Transfer Accuracy of 3D-printed Trays for Indirect Bonding of Orthodontic Brackets
This study evaluates the transfer accuracy of 3D-printed trays for indirect bonding of orthodontic brackets in vivo. Accurate placement of orthodontic brackets at the beginning of treatment improves treatment efficiency and shortens treatment time. Indirect bonding is a method of placing orthodontic brackets on a plaster or digital model of the dentition, followed by the transfer of these brackets to the patients' teeth using a transfer tray. Various indirect bonding methods have been developed with the aim of improved bracket positioning and reduced chair time. The success of these methods ultimately depends on how reliably the precise positioning of the brackets on the model can be transferred to the patient's teeth.
- Conditions
- Dental Bonding
- Being tested
- 3D printed tray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed trayDevice
3D printed tray
| Study group | Role | What they receive |
|---|---|---|
| 3D printed tray | Experimental | 3D printed tray Receives: Device: 3D printed tray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer accuracy
Transfer accuracy expressed as difference in bracket position between setup and clinical situation, as a result of the indirect bonding procedure. These differences will include both the magnitude and the direction, and will be reported in 6 dimensions; i.e. as mesial-distal, buccal-lingual, and occlusal-gingival linear differences as well as torque, tip, and rotation angular differences. Linear differences will be expressed in millimeters, angular differences will be expressed in degrees.
Measured: At time of bonding, i.e. day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start25 Aug 2020
- Primary completion25 Aug 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental BondingStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorsten Gruenheid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thorsten Gruenheid, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683874
- Sponsor's protocol ID
- 00009952
- Status last verified
- Sep 2021
- First submitted
- 18 Dec 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer Accuracy of 3D-printed Trays for Indirect Bonding of Orthodontic Brackets
- ClinicalTrials.gov ID
- NCT04683874
- Acronym / sponsor ID
- 00009952
- Conditions
- Dental Bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Thorsten GruenheidUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- 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.
This study evaluates the transfer accuracy of 3D-printed trays for indirect bonding of orthodontic brackets in vivo. Accurate placement of orthodontic brackets at the beginning of treatment improves treatment efficiency and shortens treatment time. Indirect bonding is a method of placing orthodontic brackets on a plaster or digital model of the dentition, followed by the transfer of these brackets to the patients' teeth using a transfer tray. Various indirect bonding methods have been developed with the aim of improved bracket positioning and reduced chair time. The success of these methods ultimately depends on how reliably the precise positioning of the brackets on the model can be transferred to the patient's teeth.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printed tray | Experimental | Device: 3D printed tray3D printed tray |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults and children (ages 12 years and older) who are in the permanent dentition.
Key exclusion criteria (1 listed)
- Less than 12 years of age, primary or mixed dentition, or bonded orthodontic appliances present, prosthetic restorations on the facial surfaces of teeth, craniofacial anomalies, and dental anomalies such as malformation, microdontia, or severe attrition
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 |
|---|---|---|
| 3D printed tray3D printed tray | Device | 3D printed tray |
Primary outcome
Transfer accuracy
Time frame: At time of bonding, i.e. day 1
Transfer accuracy expressed as difference in bracket position between setup and clinical situation, as a result of the indirect bonding procedure. These differences will include both the magnitude and the direction, and will be reported in 6 dimensions; i.e. as mesial-distal, buccal-lingual, and occlusal-gingival linear differences as well as torque, tip, and rotation angular differences. Linear differences will be expressed in millimeters, angular differences will be expressed in degrees.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed tray in people with Dental Bonding, run by Thorsten Gruenheid at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transfer accuracy (time frame: At time of bonding, i.e. day 1). 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 Sep 2021.