NCT06516185

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

Randomized Clinical Trial on the Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Crowding, Tooth
• Tipped Tooth or Teeth
• Rotation of Tooth
• Malocclusion, Angle's Class

Interventions

Type	Name	Description
DEVICE	direct-printed aligner	Patients will be treated with direct-printed aligners until dental alignment is achieved.
DEVICE	thermoformed aligner	Patients will be treated with thermoformed aligners until dental alignment is achieved.

Timeline

• Start date: 2024-10-22
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2024-07-23
• Last updated: 2024-12-12

Locations

1 site across 1 country: Spain