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Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement

Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement

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Overview

The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.

Description

Once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. They will also be informed that they may cancel their participation in the study at any time. Patient will be allocated randomly in two groups: The first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.

Eligibility

Inclusion Criteria:

  • Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment
  • Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries.
  • No history of previous orthodontic treatment.
  • Complete permanent dentition (excluding third molars, their presence or absence being irrelevant).

Exclusion Criteria:

  • Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs).
  • Pregnant women.

Study details
    Crowding
    Tooth
    Tipped Tooth or Teeth
    Rotation of Tooth
    Malocclusion
    Angle's Class

NCT06516185

Universidad Complutense de Madrid

14 September 2025

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