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

NCT06743360 | Active Not Recruiting

• 1 other identifier: KB-OIL/05/2024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Geometric change

  Changes of mini-implant geomtery in micrometers

  6 months

Secondary Outcomes (1)

• Surface analysis

  6 months

Study Arms (1)

Test group

Patients seeking for orthodontic treatment with the need of use of the mini-implants

Device: Insertion; Device: Scanning

Interventions

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).

Test group

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.

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients seeking orthodontic treatment with use of the orthodontic mini-implants

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• Katarzyna Stefaniak Private Practice: collaborator

Study Sites (2)

Department of Interdisciplinary Dentistry

Szczecin, West Pomeranian Voivodeship, 70111, Poland

Location

Private Dental Practice "Morze Usmiechu"

Świnoujście, West Pomeranian Voivodeship, 72600, Poland

Location

Related Publications (7)

• 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.

  PMID: 20122438 BACKGROUND

• Jedlinski 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.

  PMID: 36142951 BACKGROUND

• Chaimanee 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.

  PMID: 21261491 BACKGROUND

• Eliades 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.

  PMID: 19121491 BACKGROUND

• Patil 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.

  PMID: 25836349 BACKGROUND

• Cho 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.

  PMID: 23216058 BACKGROUND

• Francioli 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.

  PMID: 20974446 BACKGROUND

MeSH Terms

Conditions

Malocclusion; Malocclusion, Angle Class I; Malocclusion, Angle Class II

Interventions

Mutagenesis, Insertional; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: October 10, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)