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

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Crowding, Tooth; Tipped Tooth or Teeth; Rotation of Tooth; Malocclusion, Angle's Class

Treatments: Device: direct-printed aligner; Device: thermoformed aligner

Study type: Interventional

Funder types: Other

Identifiers

NCT06516185

125-120324

24/098-EC_P (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Direct-printed aligner

Experimental group

Description:

The experimental group will be treated with the aligner system fabricated by direct printing. The current protocols described in the literature and by the manufacturer for the fabrication of the printed orthodontic devices will be followed.

Treatment:

Device: direct-printed aligner

Thermoformed aligner

Active Comparator group

Description:

The control group will be treated with the thermoformed or gold standard aligner system. The established protocols for treatment with thermoformed clear aligners will be followed.

Treatment:

Device: thermoformed aligner