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| ID | Type | Description | Link |
|---|---|---|---|
| 24/098-EC_P | Registry Identifier | Ethics Committee for Research involving medicinal products (IECm) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct-printed aligner | Experimental | 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. |
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| Thermoformed aligner | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| direct-printed aligner | Device | Patients will be treated with direct-printed aligners until dental alignment is achieved. |
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| Measure | Description | Time Frame |
|---|---|---|
| Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners. | The primary outcome will be quantified through a continuous numerical variable, tooth movement efficiency or predictability (%) measured as the change between the final, intra-treatment and initial position for each of the individual movements studied, expressed as a percentage (%). The end of treatment or endpoint (E1) of this study will be established when the measurement of Little's Irregularity Index (hereafter LII) LII=0. | Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months. |
| impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries. | This will be assessed by quantifying the change between the predictability with auxiliaries and without auxiliaries for each of the individual movements studied respectively, expressed as a percentage (%). | Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMs of the patient undergoing direct-printed aligner treatment compared to the control group. | Participants will complete a validated pre-defined questionnaire [Patient-reported outcome measures (PROMs)] on treatment use and perceptions. The level of pain will be assessed using questionnaires. | These should be completed five times after each visit (at 24 hours, 48 hours, 72 hours, 7 days and 14 days of aligner use) until reaching the defined endpoint (crowding resolution, LII=0), an average of 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Piñeda-Zayas | Contact | +34626923397 | apined01@ucm.es | |
| Alejandro Iglesias-Linares | Contact | aleigl01@ucm.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense University of Madrid | Recruiting | Madrid | 28040 | Spain |
All IPD that underlie results in a publication.
Data will be available at the end of the clinical trial in June 2026
Upon request of the interested party
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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This study is designed following CONSORT guidelines as a randomized equivalence clinical trial, controlled, with two parallel arms, and single-blind.
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| thermoformed aligner | Device | Patients will be treated with thermoformed aligners until dental alignment is achieved. |
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| influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print. | This will be assessed by quantifying the change between the predictability, varying the degree of inclination of the aligner print, expressed as a percentage (%). | Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months. |