MalocclusionNCT03754283
Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays
A study testing Indirect bonding in people with Malocclusion, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Indirect bonding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Sep 2017
- 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 15 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The presence of indication for both arches to be bonded in the same appointment
Who cannot join
- Presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces
- Abnormal crown morphology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfer Accuracy of Indirectly Bonded Orthodontic Attachments With Vacuum Formed and Silicone Transfer Trays
The aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces.
Read the detailed description
The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer between double layer silicone and double layer vacuum formed trays. The sample included 368 attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed tray which were randomly allocated to provide 8 trays of each type for the upper and lower arches. 3D scan data and local best-fit alignments were used to calculate the translational and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests were used to compare transfer accuracy and success between the groups.
- Conditions
- Malocclusion
- Being tested
- Indirect bonding
- Keywords
- Indirect bonding, Accuracy
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect bondingDevice
Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays
| Study group | Role | What they receive |
|---|---|---|
| Silicone | Experimental | Indirect bonding performed with the silicone trays Receives: Device: Indirect bonding |
| Vacuum formed | Active comparator | Indirect bonding performed with the vacuum formed trays Receives: Device: Indirect bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.
The positional deviations between the attachments on the models and the mouth
Measured: Day 0 - Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Jun 2017
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cihan Aydoğan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754283
- Sponsor's protocol ID
- 03-05.04.2016
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer Accuracy of Indirectly Bonded Orthodontic Attachments With Vacuum Formed and Silicone Transfer Trays
- ClinicalTrials.gov ID
- NCT03754283
- Acronym / sponsor ID
- 03-05.04.2016
- Conditions
- Malocclusion
- Keywords
- Indirect bonding, Accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 27 Nov 2018 (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.
The aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces.
Detailed description
The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer between double layer silicone and double layer vacuum formed trays. The sample included 368 attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed tray which were randomly allocated to provide 8 trays of each type for the upper and lower arches. 3D scan data and local best-fit alignments were used to calculate the translational and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests were used to compare transfer accuracy and success between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| Silicone | Experimental | Device: Indirect bondingIndirect bonding performed with the silicone trays |
| Vacuum formed | Active comparator | Device: Indirect bondingIndirect bonding performed with the vacuum formed trays |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The presence of indication for both arches to be bonded in the same appointment
Key exclusion criteria (2 listed)
- Presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces
- Abnormal crown morphology
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 |
|---|---|---|
| Indirect bondingIndirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays | Device | Silicone, Vacuum formed |
Primary outcome
Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.
Time frame: Day 0 - Day 2
The positional deviations between the attachments on the models and the mouth
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 27 Nov 2018.
- 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 Indirect bonding in people with Malocclusion, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 2 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 27 Nov 2018. 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 Turkey (Türkiye). 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 (composite outcome) in milimetres and degrees. Which is measured on computer software. (time frame: Day 0 - Day 2). 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 27 Nov 2018.