Crowding, Tooth, Malocclusion, Angle's Class, Rotation of Tooth, Tipped Tooth or Teeth
Conditions
Keywords
clear aligner therapy, direct-printed aligner, predictability, shape memory, stratification
Brief 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.
Interventions
DEVICEdirect-printed aligner
Patients will be treated with direct-printed aligners until dental alignment is achieved.
DEVICEthermoformed aligner
Patients will be treated with thermoformed aligners until dental alignment is achieved.
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This study is designed following CONSORT guidelines as a randomized equivalence clinical trial, controlled, with two parallel arms, and single-blind.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months. | 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. |
| impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries. | Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months. | 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 (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMs of the patient undergoing direct-printed aligner treatment compared to the control group. | 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. | 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. |
| influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print. | Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months. | This will be assessed by quantifying the change between the predictability, varying the degree of inclination of the aligner print, expressed as a percentage (%). |
Countries
Spain
Contacts
Primary ContactAlejandro Piñeda-Zayas
Backup ContactAlejandro Iglesias-Linares
Outcome results
None listed