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

Active, not recruiting

• Conditions: Malocclusions; Malocclusion, Angle Class I; Malocclusion, Angle Class II

• Registration Number: NCT06743360
• Lead Sponsor: Pomeranian Medical University Szczecin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-10
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric change	6 months	Changes of mini-implant geomtery in micrometers

Secondary Outcome Measures

Name	Time	Method
Surface analysis	6 months	Analysis of irregularities and wear pattern of removed mini-implant

Trial Locations

Locations (2)

Private Dental Practice "Morze Usmiechu"; 🇵🇱 Swinoujscie, Zachodniopomorskie, Poland

Department of Interdisciplinary Dentistry; 🇵🇱 Szczecin, Zachodniopomorskie, Poland