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Microanalysis of Changes in 3D Geometry of Orthodontic Mini-implants

Microanalysis of Changes in 3D Geometry of Orthodontic Mini-implants After Insertion

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06743360
Enrollment
20
Registered
2024-12-19
Start date
2024-10-10
Completion date
2025-03-01
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusions, Malocclusion, Angle Class I, Malocclusion, Angle Class II

Keywords

orthodontic mini-implants, skeletal anchorage, orthodontic miniscrews, orthodontic mini-screws, temporary anchorage device, TAD, 3D superimpostion, geometric changes

Brief 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. 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.

Interventions

DEVICEInsertion

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).

DEVICEScanning

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.

Sponsors

Katarzyna Stefaniak Private Practice
CollaboratorUNKNOWN
Pomeranian Medical University Szczecin
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Geometric change6 monthsChanges of mini-implant geomtery in micrometers

Secondary

MeasureTime frameDescription
Surface analysis6 monthsAnalysis of irregularities and wear pattern of removed mini-implant

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026