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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malocclusion, Angle Class II; Malocclusion, Angle Class I; Malocclusions
• Intervention / Treatment: Device: Insertion; Device: Scanning

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Poland
  • Zachodniopomorskie
    • Swinoujscie, Zachodniopomorskie, Poland, 72600
      • Private Dental Practice "Morze Usmiechu"
    • Szczecin, Zachodniopomorskie, Poland, 70111
      • Department of Interdisciplinary Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric change	Changes of mini-implant geomtery in micrometers	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface analysis	Analysis of irregularities and wear pattern of removed mini-implant	6 months

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Collaborators: Katarzyna Stefaniak Private Practice

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: TAD; skeletal anchorage; temporary anchorage device; orthodontic miniscrews; orthodontic mini-implants; orthodontic mini-screws; 3D superimpostion; geometric changes
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class I; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: KB-OIL/05/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No need.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No