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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
Patients will be treated with direct-printed aligners until dental alignment is achieved.
Patients will be treated with thermoformed aligners until dental alignment is achieved.
Complutense University of Madrid
Madrid, Spain
RECRUITINGPredictability 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.
Time frame: 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 (%).
Time frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
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.
Time frame: 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.
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 (%).
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Time frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.