MalocclusionsNCT06743360
Microanalysis of Changes in 3D Geometry of Orthodontic Mini-implants
An observational study of Malocclusions and Malocclusion, Angle Class I, run by Pomeranian Medical University Szczecin at 2 sites in Poland.
Trial summary
The orthodontic mini-implants used in the study are temporary screws inserted into the bone to provide anchorage for challenging tooth movements that could not be carried out using the patient's own teeth. They are made of a medical grade titanium alloy (Ti6Al4Va), with a length of 8 mm and a diameter of 1.3 mm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusions, Malocclusion, Angle Class I, Malocclusion, Angle Class II
- What is being tested?
- Insertion and Scanning
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesPoland
- Study dates
- 10 Oct 2024to 1 Mar 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seeking orthodontic treatment with use of the orthodontic mini-implants
Who may be able to join
- Adult patient in the active phase of orthodontic treatment with a fixed orthodontic appliance.
- The individual treatment plan involving tooth movements that require anchorage reinforcement: asymmetric intrusion, space closure through mesialization or distalization.
- Clinical indications and the possibility of placing a mini-implant in the interradicular space of the maxillary/mandibular alveolar bone (possibility of using the AbsoAnchor SH1312-08 mini-implant).
- Informed consent of the patient.
Who cannot join
- Individualized treatment plan involving the use of a mini-implant different from the one used in the study.
- Lack of consent for participation in the study.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Private Dental Practice "Morze Usmiechu"
Świnoujście, West Pomeranian Voivodeship, 72600
Department of Interdisciplinary Dentistry
Szczecin, West Pomeranian Voivodeship, 70111
About this study
Official title: Microanalysis of Changes in 3D Geometry of Orthodontic Mini-implants After Insertion
The orthodontic mini-implants used in the study are temporary screws inserted into the bone to provide anchorage for challenging tooth movements that could not be carried out using the patient's own teeth. They are made of a medical grade titanium alloy (Ti6Al4Va), with a length of 8 mm and a diameter of 1.3 mm. After the completion of the treatment phase requiring specific anchorage, they are removed and disposed of as a medical waste.
The insertion of the mini-screw is conditioned by the individual treatment plan and the treatment protocol would not differ from the standard treatment.
The aim of the project is to analyze changes in the macrogeometry and wear of the surfaces of retrieved orthodontic micro-implants after their clinical use. Upon completion of clinical tasks, the mini-screws will be removed and retrieved for laboratory phase of the study. The laboratory phase will consist of: microscopic and profilometric examinations, as well as scanning before insertion and after removal of the mini-implants, and a clinical phase: the use of previously scanned and sterilized mini-implants in patients participating in the study.
- Being tested
- Insertion, Scanning
- Keywords
- orthodontic mini-implants, skeletal anchorage, orthodontic miniscrews, orthodontic mini-screws, temporary anchorage device, TAD, 3D superimpostion, geometric changes
- Medical subject headings
- Malocclusion, Malocclusion, Angle Class I, Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsertionDevice
Twenty orthodontic mini-implants (n=20) (AbsoAnchor SH 1312-08, Dentos, Daegu, South Korea) were randomly chosen (every third screw from a sample of 60) numbered consecutively, and embedded in polivynyl siloxane impression material Variotype heavy putty (Kulzer, Hanau, Germany).
ScanningDevice
After the planned movement is achieved, the mini-implant will be removed and provided to laboratory analysis. All screws were sputtered (0.6µm CaCO₄) and scanned in blue-light technology, using a 3D optical scanner (Atos III, Triple Scan, GOM, Germany) to the nearest 2 micrometres. Due to regularly performed calibration procedures, recommended by the manufacturer, an error study was superfluous. Subsequently, the scans were superimposed using GOM Inspect Software (GOM, Braunschweig, Germany) in order to verify the shape and size repeatability.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Patients seeking for orthodontic treatment with the need of use of the mini-implants Receives: Device: Insertion; Device: Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric change
Changes of mini-implant geomtery in micrometers
Measured: 6 months
Secondary outcomes (1)
Surface analysis
Analysis of irregularities and wear pattern of removed mini-implant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start10 Oct 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalocclusionsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Collaborators
- Katarzyna Stefaniak Private Practice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743360
- Sponsor's protocol ID
- KB-OIL/05/2024
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No need.
Publications
Crismani AG, Bertl MH, Celar AG, Bantleon HP, Burstone CJ. Miniscrews in orthodontic treatment: review and analysis of published clinical trials. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):108-13. doi: 10.1016/j.ajodo.2008.01.027.
PubMed 20122438Jedlinski M, Janiszewska-Olszowska J, Mazur M, Grocholewicz K, Suarez Suquia P, Suarez Quintanilla D. How Does Orthodontic Mini-Implant Thread Minidesign Influence the Stability?-Systematic Review with Meta-Analysis. J Clin Med. 2022 Sep 9;11(18):5304. doi: 10.3390/jcm11185304.
PubMed 36142951Chaimanee P, Suzuki B, Suzuki EY. "Safe zones" for miniscrew implant placement in different dentoskeletal patterns. Angle Orthod. 2011 May;81(3):397-403. doi: 10.2319/061710-111.1. Epub 2011 Jan 24.
PubMed 21261491Eliades T, Zinelis S, Papadopoulos MA, Eliades G. Characterization of retrieved orthodontic miniscrew implants. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):10.e1-7; discussion 10-1. doi: 10.1016/j.ajodo.2008.06.019.
PubMed 19121491Patil P, Kharbanda OP, Duggal R, Das TK, Kalyanasundaram D. Surface deterioration and elemental composition of retrieved orthodontic miniscrews. Am J Orthod Dentofacial Orthop. 2015 Apr;147(4 Suppl):S88-100. doi: 10.1016/j.ajodo.2014.10.034.
PubMed 25836349Cho IS, Kim TW, Ahn SJ, Yang IH, Baek SH. Effects of insertion angle and implant thread type on the fracture properties of orthodontic mini-implants during insertion. Angle Orthod. 2013 Jul;83(4):698-704. doi: 10.2319/082812-689.1. Epub 2012 Dec 10.
PubMed 23216058Francioli D, Ruggiero G, Giorgetti R. Mechanical properties evaluation of an orthodontic miniscrew system for skeletal anchorage. Prog Orthod. 2010;11(2):98-104. doi: 10.1016/j.pio.2010.04.014. Epub 2010 May 15.
PubMed 20974446
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microanalysis of Changes in 3D Geometry of Orthodontic Mini-implants After Insertion
- ClinicalTrials.gov ID
- NCT06743360
- Acronym / sponsor ID
- KB-OIL/05/2024
- Keywords
- orthodontic mini-implants, skeletal anchorage, orthodontic miniscrews, orthodontic mini-screws, temporary anchorage device, TAD, 3D superimpostion, geometric changes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Collaborators
- Katarzyna Stefaniak Private Practice
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 19 Dec 2024 (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 orthodontic mini-implants used in the study are temporary screws inserted into the bone to provide anchorage for challenging tooth movements that could not be carried out using the patient's own teeth. They are made of a medical grade titanium alloy (Ti6Al4Va), with a length of 8 mm and a diameter of 1.3 mm. After the completion of the treatment phase requiring specific anchorage, they are removed and disposed of as a medical waste.
The insertion of the mini-screw is conditioned by the individual treatment plan and the treatment protocol would not differ from the standard treatment.
The aim of the project is to analyze changes in the macrogeometry and wear of the surfaces of retrieved orthodontic micro-implants after their clinical use. Upon completion of clinical tasks, the mini-screws will be removed and retrieved for laboratory phase of the study. The laboratory phase will consist of: microscopic and profilometric examinations, as well as scanning before insertion and after removal of the mini-implants, and a clinical phase: the use of previously scanned and sterilized mini-implants in patients participating in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Device: Insertion, Device: ScanningPatients seeking for orthodontic treatment with the need of use of the mini-implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking orthodontic treatment with use of the orthodontic mini-implants
Key inclusion criteria (4 listed)
- Adult patient in the active phase of orthodontic treatment with a fixed orthodontic appliance.
- The individual treatment plan involving tooth movements that require anchorage reinforcement: asymmetric intrusion, space closure through mesialization or distalization.
- Clinical indications and the possibility of placing a mini-implant in the interradicular space of the maxillary/mandibular alveolar bone (possibility of using the AbsoAnchor SH1312-08 mini-implant).
- Informed consent of the patient.
Key exclusion criteria (2 listed)
- Individualized treatment plan involving the use of a mini-implant different from the one used in the study.
- Lack of consent for participation in the study.
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 |
|---|---|---|
| InsertionTwenty orthodontic mini-implants (n=20) (AbsoAnchor SH 1312-08, Dentos, Daegu, South Korea) were randomly chosen (every third screw from a sample of 60) numbered consecutively, and embedded in polivynyl siloxane impression material Variotype heavy putty (Kulzer, Hanau, Germany). | Device | Test group |
| ScanningAfter the planned movement is achieved, the mini-implant will be removed and provided to laboratory analysis. All screws were sputtered (0.6µm CaCO₄) and scanned in blue-light technology, using a 3D optical scanner (Atos III, Triple Scan, GOM, Germany) to the nearest 2 micrometres. Due to regularly performed calibration procedures, recommended by the manufacturer, an error study was superfluous. Subsequently, the scans were superimposed using GOM Inspect Software (GOM, Braunschweig, Germany) in order to verify the shape and size repeatability. | Device | Test group |
Primary outcome
Geometric change
Time frame: 6 months
Changes of mini-implant geomtery in micrometers
1 secondary outcome
Surface analysis
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 20122438Crismani AG, Bertl MH, Celar AG, Bantleon HP, Burstone CJ. Miniscrews in orthodontic treatment: review and analysis of published clinical trials. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):108-13. doi: 10.1016/j.ajodo.2008.01.027.
- Background: PubMed 36142951Jedlinski M, Janiszewska-Olszowska J, Mazur M, Grocholewicz K, Suarez Suquia P, Suarez Quintanilla D. How Does Orthodontic Mini-Implant Thread Minidesign Influence the Stability?-Systematic Review with Meta-Analysis. J Clin Med. 2022 Sep 9;11(18):5304. doi: 10.3390/jcm11185304.
- Background: PubMed 21261491Chaimanee P, Suzuki B, Suzuki EY. "Safe zones" for miniscrew implant placement in different dentoskeletal patterns. Angle Orthod. 2011 May;81(3):397-403. doi: 10.2319/061710-111.1. Epub 2011 Jan 24.
- Background: PubMed 19121491Eliades T, Zinelis S, Papadopoulos MA, Eliades G. Characterization of retrieved orthodontic miniscrew implants. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):10.e1-7; discussion 10-1. doi: 10.1016/j.ajodo.2008.06.019.
- Background: PubMed 25836349Patil P, Kharbanda OP, Duggal R, Das TK, Kalyanasundaram D. Surface deterioration and elemental composition of retrieved orthodontic miniscrews. Am J Orthod Dentofacial Orthop. 2015 Apr;147(4 Suppl):S88-100. doi: 10.1016/j.ajodo.2014.10.034.
- Background: PubMed 23216058Cho IS, Kim TW, Ahn SJ, Yang IH, Baek SH. Effects of insertion angle and implant thread type on the fracture properties of orthodontic mini-implants during insertion. Angle Orthod. 2013 Jul;83(4):698-704. doi: 10.2319/082812-689.1. Epub 2012 Dec 10.
- Background: PubMed 20974446Francioli D, Ruggiero G, Giorgetti R. Mechanical properties evaluation of an orthodontic miniscrew system for skeletal anchorage. Prog Orthod. 2010;11(2):98-104. doi: 10.1016/j.pio.2010.04.014. Epub 2010 May 15.
- Individual participant dataSharing planned: No. No need.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusions and Malocclusion, Angle Class I, run by Pomeranian Medical University Szczecin at 2 sites in Poland.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Geometric change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743360, which also lists 7 linked publications.
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 24 Dec 2024.