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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record status
This record was last updated December 24, 2024 (before its estimated February 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints: details revised at 1 of 1 entry
    • Study sites revised (2)
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06743360
Lead Sponsor Pomeranian Medical University Szczecin
Collaborators: Katarzyna Stefaniak Private Practice
Conditions
(from sponsor)		 Malocclusions, Malocclusion, Angle Class I, Malocclusion, Angle Class II
Related terms Malocclusion, Malocclusion, Angle Class I, Malocclusion, Angle Class II
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov