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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Malocclusions Malocclusion Malocclusion, Angle Class I Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Interdisciplinary Dentistry, Szczecin, West Pomeranian Voivodeship, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insertion

Device

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).

Scanning

Device

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.

Primary outcomes

Geometric change

Time frame: 6 months

Changes of mini-implant geomtery in micrometers

Secondary outcomes

Surface analysis

Time frame: 6 months

Analysis of irregularities and wear pattern of removed mini-implant

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Collaborators

Katarzyna Stefaniak Private Practice

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 19, 2024
Registry last updated: Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting