Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidad Complutense de Madrid
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs).
Pregnant women.
Trial design
Design model
Parallel
Treatments tested in this trial
direct-printed aligner
DevicePatients will be treated with direct-printed aligners until dental alignment is achieved.
thermoformed aligner
DevicePatients will be treated with thermoformed aligners until dental alignment is achieved.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Direct-printed alignerExperimental treatment 1 intervention
Group B: Thermoformed alignerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.2
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.Secondary outcomes
1
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.2
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 (%).
Time frame
Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.Sponsors and contacts
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Source ClinicalTrials.gov