NCT06743360

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
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Pomeranian Medical University Szczecin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Insertion	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).
DEVICE	Scanning	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.

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-02-01
• Completion: 2025-03-01
• First posted: 2024-12-19
• Last updated: 2024-12-24

Locations

2 sites across 1 country: Poland