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

P

Pomeranian Medical University Szczecin

Status

Active, not recruiting

Conditions

Malocclusion, Angle Class II
Malocclusions
Malocclusion, Angle Class I

Treatments

Device: Insertion
Device: Scanning

Study type

Observational

Funder types

Other

Identifiers

NCT06743360
KB-OIL/05/2024

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Test group
Description:
Patients seeking for orthodontic treatment with the need of use of the mini-implants
Treatment:
Device: Scanning
Device: Insertion

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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